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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79088

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 15, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Medical Systems (Cleveland) Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

BrightView X, Model #882478 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).

Z-0510-2018
Recall number
Z-0510-2018
Initiated
December 15, 2017
Classification
Class II
Status
Terminated
Quantity
1387 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.

Code information

BrightView X, Model # 882478 Serial Numbers: 11000044 11000006 11000033 11000025 11000105 11000016 11000072 11000116 11000003 11000018 11000066 11000047 11000101 11000065 11000114 11000078 11000051 11000046 11000026 11000007 11000010 11000027 11000032 11340001 11000055 11000070 11000084 11000088 11000068 11000052 11000057 11000050 11000067 11000102 11000061 11000095 11000023 11000094 11000060 11000054 11340004 11000083 11000091 11000098 4000570 11000063 11000062 11000013 11000015 11000035 11000081 11000009 11000017 11000110 11000090 11000107 11340003 11000056 11000029 11000100 11000019 11000034 11000020 11000112 11000086 11000045 11000092 11000037 11000106 11000038 11000059 11000064 11000039 11000087 11000004 11000058 11000030 11340005 11000113 11000117 11000011 11000118 11000074 11000075 11000036 11000104 11000103 11000071 11340002 11000089 11000012 11000041 11000042 11000043 11000049 11000014 11000099 11000022 11000031 11000005 11000028 11000073 11000040 11000077 11000008 11000048 11000093 11000096 11000097 11000069 11000079 11000080 11000024 11000076 11000085 11000108 11000109 11000115

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 2 of 5

BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals.

Z-0511-2018
Recall number
Z-0511-2018
Initiated
December 15, 2017
Classification
Class II
Status
Terminated
Quantity
1387 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.

Code information

Brightview XCT Model 882482 Serial Numbers : 6000241 6000290 6000291 6000292 6000306 6000289 6000304 6000374 6000237 6000317 6000235 6000318 6000167 6000194 6000229 6000391 6000352 6000220 6000054 6000060 6000195 6000204 6000206 6000295 6000203 6000043 6000082 6000402 6000056 6000026 6000228 6000171 6000355 6000089 6000033 6000053 6000094 6000093 6000165 6000199 6000349 6000219 6000396 6000163 11000021 6000325 6000022 6000015 6000020 6000047 6000130 6000184 6000330 6000147 6000123 6000077 6000128 6000251 6000066 6000131 6000132 6000338 6000310 6000309 6000269 6000210 6000012 6000037 6000416 6000339 6000276 6000115 6000126 6000109 6000113 6000051 6000351 6000201 6000332 6000013 6000368 6000370 6000215 6000127 6000236 6000006 6000038 6000045 6000065 6000173 6000084 6000187 6000186 6000070 6000183 6000185 6000188 6000090 6000072 6000078 6000182 6000074 6000036 6000334 6000380 6000296 6000246 6000081 6000083 6000086 6000025 6000029 6000174 6000234 6000363 6000406 6000389 6000233 6000224 6000121 6000145 6000342 6000156 6000300 6000211 6000212 6000303 6000333 6000367 6000407 6000320 6000240 6000129 6000319 6000271 6000041 6000262 6000293 6000307 6000329 6000354 11000082 6000255 6000216 6000337 6000274 6000227 6000256 6000384 6000064 6000398 6000101 6000133 6000238 6000400 6000062 6000222 6000100 6000190 6000103 6000265 6000336 6000181 6000010 6000105 6000371 6000032 6000346 6000226 6000321 6000141 6000067 6000068 6000075 6000273 6000350 6000281 6000168 6000359 6000061 6000427 6000166 6000169 6000048 6000055 6000362 6000358 6000125 6000280 6000418 6000341 6000421 6000205 6000365 6000157 6000326 6000155 6000249 6000044 6000120 6000315 6000385 6000299 6000027 6000079 6000193 6000099 600009 6000124 6000017 6000139 6000247 6000426 6000046 6000102 6340008 6000176 6000347 6000410 6000414 6000305 6340010 6000039 6000260 6000267 6000392 6000343 6000268 6000223 6000323 6000294 6000428 6000264 6000252 6000413 6000154 6000242 6000243 6000298 6000314 6000423 6000424 6000425 6000138 6000050 6000297 6000207 6000098 6000144 6000096 6000230 6000254 6000257 6000270 6000357 6000302 6000200 6000328 6000059 6000097 6000111 6000259 6000049 6000379 6000258 6000192 6000005 6000278 6000035 6000202 6000376 6000375 6000221 6000119 6000415 6000282 6000057 6000164 6000261 6000104 6000088 6000136 6000118 6000080 6000231 6000151 6000369 6000180 6000085 6000244 6000073 6000018 6000191 6000122 6000422 6000189 6000011 6000152 6000213 6000175 6000272 6000313 6000263 6000324 6000071 6000312 6000112 6000409 6000372 6000217 6000388 6000364 6000218 6000420 6000403 6000381 6000393 6000411 6000419 6000275 6000177 6000135 6000146 6000076 6000069 6000179 6000266 6000232 6000239 6000377 6000353 6000373 6000387 6000361 6000366 6000383 6000322 6000052 6000004 6000378 6000042 6000160 6000159 6000140 6000408 6000153 6000284 6000091 6000277 6000335 6000356 6000040 6000016 6000208 6000209 6000417 6000360 6000412 6000004A 6000390 6000198 6000214 6000114 6000316 6000245 6000172 6000178 6000143 6000285 6000108 6000087 6000345 6000386 6000107 6000116 6000063 6000344 6000023 6000028 6000279 6000058 6000197 6000331 6000149 6000327 6000401 6000196 6000002 6000134 6000158 6000394 6000395 6340009 6000162 6000311 6000019 11000111 6000382 6000283 6000142 6000024 6000031 6000253 6000110 6000030 6000161 6000250 6000288 6000117 6000003 6000308 6000106 6000348 6000286 6000150 6000287 6000405 6340011 6000225 6000399 6000404 6000340 6000092 6000095 6000148 6000170 6000014 6000006A 6000301 6000005A 5340007

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 3 of 5

BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).

Z-0512-2018
Recall number
Z-0512-2018
Initiated
December 15, 2017
Classification
Class II
Status
Terminated
Quantity
1387 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.

Code information

Brightview Model 882480 Serial Numbers : 4000410 4000651 4000652 4000665 4000688 4000350 4000065 4000061 4000180 4000224 4000321 4000298 4000552 4000280 4000378 4000336 4000559 4000229 4000262 4000681 4000009 4000184 4000554 4000516 4000303 4000576 4000190 4000305 4000411 4000669 4000614 4000324 4000612 4000566 4000627 4000218 4000123 4000287 4000070 4000166 4000202 4000102 4000276 4000091 4000301-1 4000455 4000033 4000364 4000008 4000497 4000498 4000699 4000012 4000213 4000413 4000472A 4000581 4000469 4000648 4000510 4000454 4000335 4000436 4000353 4000418 4000491 4000571 4000197 4000555 4000518 4000544 4000500 4000592 4000617 4000005 4000379 4000451 4000533 4000602 4000137 4000343 4000030 4000540 4000316 4000342 4000408 4000421 4000495 4000511 4000664 4000317 4000338 4000604 4000682 4000647 4000341 4000057-OLD 4000389 4000290 4000283 4000312 4000328 4000375 4000560 4000366 4000417 4000051 4000372 4000151 4000422 4000195 4000088 4000381 4000071 4000003 4000549 4000487 4000056 4000006 4000466 4000550 4000346 4000683 4000483 4000301 4000158 4000223 4000129 4000045 4000057 4000557 4000567 4000370 4000536 4000029 4000607 4000067 4000068 4000032 4000423 4000039 4000031 4000620 4000678 4000601 4000122 4000286 4000294 4000395 4000672 4000348 4000613 4000655 4000390 4000419 4000462 4000463 4000464 4000638 4000296 4000199 4000096 4000281 4000288 10422 199 281 288 422 4000002 4000268 4000382 4000692 4000693 4000337 4000595 4000447 4000273 4000169 4000442 4000412 4000488 4000297 4000228 4000156 4000047 4000049 4000107 4000227 4000105 4000698 4000333 4000339 4000385 4000109 4000115 4000356 4000257 4000173 4000126 4000121 4000494 4000398 4000503 4000386 4000399 4000179 4000600 4000400 4000397 4000194 4000154 4000504 4000233 4000256 4000667 4000401 4000394 4000585 4000168 4000631 4000354 4000493 4000072 4000237 4000272 4000478 4340004 4000219 4000485 4000643 4000376 4000416 4000243 4000437 4000694 4000551 4000035 4000645 4000691 4000427 4000515 4000548 4000183 4000142 4000066 4000226 4000475 4000519 4000459 4000461 4000468 4000063 4000150 4000210 4000217 4000547 4000689 4000420 4000690 4000530 4000639 4000479 4000568 4000300 4000572 4000573 4000640 4000013 4000075 4000080 4000086 4000392 4000396 4000481 4000428 4000157 4000374 4000543 4000041 4000167 4000203 4000407 4000621 4000676 4000477 4000299 4000133 4000675 4000314 4000686 4000209 4000010 4000539 4000663 4000082 4000134 4000163 4000373 4000409 4000465 4000471 4000545 4000618 4000637 4000641 4000153 4000331 4000211 4000484 4340005 4000044 4000393 4000282 4000449 4000679 4000279 4000208 4000216 4000269 4000125 4000254 4000345 4000415 4000586 4000327 4000307 4000361 4000146 4000159 4000077 4000050 4000687 4000325 4000165 4000252 4000315 4000191 4000598 4000141 4000565 4000135 4000537 4000591 4000311 4000626 4000636 4000329 4000181 4000644 4000171 4000120 4000484A 4000441 4000054 4000110 4000653 4000590 4000100 4000520 4000323 4000403 4000406 4000489 4000277 4000306 4000332 4000635 4000270 4000302 4000046 4000214 4000615 4000187 4000660 4000383 4000633 4000322 4000212 4000628 4000034 4000232 4000668 4000480 4000430 4000553 4000467 4000221 4000127 4000259 4000670 4000193 4000222 4000289 4000597 4000439 4000542 4000531 4000588 4000358 4000330 4000508 4000310 4000371 4000501 4000609 4000616 4000116 4000452 4000058 4000521 4000059 4000064 4000482 4000384 4000528 4000177 4000506 4000278 4000089 4000139 4000130 4000564 4000578 4000674 4000083 4000583 4000225 4000267 4000563 4000587 4000117 4000053 4000662 4000526 4000207 4000118 4000103 4000556 4000247 4000326 4000174 4000248 4000642 4000696 4000182 4000456 4000060 4000522 4000448 4000099 4000246 4000175 4000524 4000630 4000155 4000367 4000360 4000492 4000037 4000230 4000308 4000236 4000143 4000285 4000505 4000206 4000684 4000164 4000004 4000650 4000671 4000473 4000405 4000235 4000242 4000680 4000318 4000561 4000149 4000073 4000240 4000606 4000610 4000304 4000584 4000580 4000460 4000263 4000347 4000632 4000265 4000368 4000055 4000349 4000658 4000351 4000388 4000589 4000558 4000106 4000144 4000444 4000292 4000098A 4000319 4000245 4000295 400054 4000470 4000666 4000111 4000148 4000076 4000443 4000575 4000654 4000251 4000108 4000657 4000659 4000562 4000535 4000435 4000357 4000677 4000453 4000377 4000387 4000446 4000608 40007060008 4000036 4000433 4000538 4000474 4000414 4000569 4000266 4000204 4000119 4000079 4000234 4000253 4000192 4000249 4000634 4000152 4000380 4000513 4000198 4000313 4000340 4000525 4000541 4000231 4000424 4000161 4000170 4000048 4000239 4000124 4000200 40007050005 40007060007 4000625 4000264 4000534 4000261 4000359 4000220 4000136 4000140 4000355 4000087 4000104 4000611 4000002 4000040 4000093 4000258 4000352 4000291 4000132 4000334 4000486 4000271 4000599 4000605 4000196 4000363 4000656 4000362 4000074 4000577 4000151-1 4000238 4000007 4000113 4000284 4000260 4000244 4000391 4000344 4000695 4000112 4000205 4000250 4000052 4000432 4000275 4000185 4000646 4000094 4000215 4000507 4000090 40000101 4000582 4000594 4000128 4000661 4000431 4000703001 4000523 4000078 4000425 4000062 4000145 4000011 4000426 4000440 4000529 4000450 4000509 4000241 4000320 40000092 4000603 4000496 4000532 4000502 4000255 4000593 4000490 4000293 4000434 4000619 4000438 4000095 4000499 4000623 4000517 4000624 4000402 4000162 4000574 4000476 4000629 4000649 4000685 4000596 4000160 4000546 4000622 4000186 4000189 4000445 4000429 4000274 4000697 4000673 4000038 4000404 4000176 4000114 4000309 4000138 4000188 4000369 4000178 4000043 4000002 3/4 4000081 40007030003 40007060006 4000579 4000527 4000201

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 4 of 5

Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals.

Z-0513-2018
Recall number
Z-0513-2018
Initiated
December 15, 2017
Classification
Class II
Status
Terminated
Quantity
1387 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.

Code information

Precedence 6 Model # 882351 Serial Numbers : KP06080001 KP06090002 3000027 3000028 747866A0 KP06020006 30007020021 KP06080010 3000030 KP06090012 KP06100013 KP06110015 30007030020 30007010017 30007030021 30007060024 30007070025 30007050023 30007050022 3000029 3000036 3000002 3000040 3000031 3000032 3000033 3000038 3000035 3000034 3000039 H3000037 3000042 3000041 3000043 3000044 3000046 3000045 30007030016 3000003 3000037 6111502 KP06070007 KP06080008

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 5 of 5

Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals.

Z-0514-2018
Recall number
Z-0514-2018
Initiated
December 15, 2017
Classification
Class II
Status
Terminated
Quantity
1387 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.

Code information

Precedence 6 Model # 882351 Serial Numbers : KP05100002 KP06040012 KP05040006 KP05080007 KP05110003 KP0510008 30008 KP06110019 K06110017 6080522 30007060027 3000034 3000032 30007060029 3000006 KP06020011 KP06050013 KP06080008 KP05110004 KP06110018 30007040026 KP06070015 30007060028 3000033 30007030025 3000031 3000035 3000040 3000041 30058 3000049 3000054 3000039 3000038 3000042 3000093 3000044 3000036 3000043 3000047 KP06070048 3000074 3000059 3000055 340090 3000057 3000058 3000053 3000050 3000056 3000052 3000061 3000051 3000045 3000048 3000069 3000066 3000078 3000060 3000064 3000068 3000065 30007070030 3000071 3000063 3000067 3000062 300072 3000095 3000073 3000085 30007080011 30007040024 3000102 3000075 3000076 7021 3000092 3000098 3000087 3000077 3000082 3000080 3000081 3000088 3000079 3000083 3000084 3000089 3000091 3000096 3000097 3000100 3000086 3000090 3000099 3000094 3000104 3000101 3000103 3000105 3000106 3000037 3000708005 30006120020 30007020023

Distribution pattern

Worldwide Distribution - US Nationwide