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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93643

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

Open FDA event record

Event summary

Timeline bucket
November 30, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Philips North America

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

3 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 3

BrightView, Gamma Camera System, Product Code 882480.

Z-0677-2024
Recall number
Z-0677-2024
Initiated
November 30, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America
Quantity
359 US; 328 OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.

Code information

No UDI Serial numbers 4000002 4000262 4000681 4000218 4000413 4000312 4000389 4000678 4000484 4000288 4000393 4000393 4000494 4000354 4000699 4000515 4000679 4000479 4000689 4000082 4000373 4000471 4000545 4000331 4000038 4000002 4000060 4000161 4000164 4000360 4000175 4000244 4000186 4000242 4000235 4000255 4000247 4000320 4000347 4000367 4000402 4000430 4000473 4000591 4000537 4000505 4000529 4000524 4000562 4000582 4000606 4000583 4000584 4000662 4000674 4000696 4000282 4000449 7135_11 4000410 4000651 4000652 4000665 4000688 4000350 4000044 4000061 4000081 4000065 4000002.75 4000180 4000224 4000321 4000229 4000280 4000378 4000559 4000552 4000298 4000009 4000190 4000184 4000305 4000303 4000324 4000411 4000516 4000554 4000566 4000576 4000614 4000612 4000627 4000669 4000033 4000070 4000091 4000123 4000102 4000008 4000202 4000166 4000276 4000287 4000364 4000455 4000498 4000497 4000012 4000213 4000197 4000353 4000335 4000418 4000510 4000436 4000454 4000469 4000500 4000491 4000518 4000472A 4000544 4000555 4000592 4000581 4000571 4000617 4000648 4000042 4000005 4000379 4000451 4000533 4000602 4000032 4000029 4000039 4000056 4000051 4000068 4000067 4000045 4000071 4000088 4000006 4000129 4000158 4000003 4000290 4000370 4000283 4000366 4000372 4000328 4000375 4000346 4000336 4000122 4000422 4000417 4000223 4000423 4000301 4000057 4000151 4000197_1 4000487 4000466 4000381 4000536 4000549 4000557 4000550 4000031 4000560 4000567 4000483 4000620 4000607 4000601 4000683 4000343 4000540 4000547 4000316 4000317 4000338 4000408 4000342 4000421 4000511 4000495 4000604 4000664 4000682 458008 4000041 4000030 4000167 4000203 4000407 4000341 4000647 4000125 4000279 4000216 4000269 4000254 4000208 4000345 4000415 4000672 4000286 4000294 4000395 4000390 4340005 4000199 4000281 4000211 4000096 4000348 4000613 4000655 4000419 4000464 4000463 4000462 4000638 4000156 4000049 4000047 4000412 4000268 4000273 4000228 4000382 4000297 4000337 4000169 4000447 4000442 4000488 4000595 4000693 4000692 4000105 4000109 4000107 4000115 4000126 4000121 4000154 4000173 4000179 4000168 4000194 4000227 4000256 4000233 4000257 4000333 4000339 4000356 4000386 4000385 4000401 4000400 4000399 4000397 4000398 4000503 4000504 4000585 4000600 4000631 4000667 4000698 4000072 4000237 4000493 40000699 4000296 4000272 4000478 4000243 4000376 4000416 4000437 4000485 4000219 4000643 4000694 4340004 4000035 4000551 4000691 4000548 4000427 6000046 4000100 4000394 4000459 4000468 4000461 4000210 4000217 4000063 4000150 4000645 4000066 4000142 4000183 4000226 4000475 4000519 4000300 4000420 4000530 4000568 4000572 4000573 4000639 4000640 4000690 4000075 4000080 4000086 4000013 4000396 4000392 4000481 4000157 4000428 4000374 4000621 4000539 4000663 4000153 4000163 4000465 4000134 1406-37 4000409 4000618 4000637 4000641 4000133 4000010 4000209 4000299 4000314 4000477 4000676 4000675 4000686 4000055 4000034 4000040 4000037 4000098A 4000036 4000074 4000046 4000064 4000059 4000050 4000094 4000052 4000048 4000053 40007050005 4000077 4000090 40000101 4000073 4000054 4000087 4000078 4000076 4000095 4000703001 40007060008 4000062 4000089 4000099 4000004 4000083 4000058 4000093 4000149 4000079 4000111 4000117 4000120 4000119 4000110 4000358 4000116 4000196 4000108 4000185 4000103 40000092 4000140 4000241 4000104 4000127 4000136 4000112 4000145 4000189 4000266 4000124 4000234 4000118 4000007 4000113 4000128 4000135 4000130 4000114 4000205 4000043 4000137 4000334 4000143 4000249 4000132 4000011 4000492 4000141 4000160 4000106 4000144 4000146 4000148 4000138 4000267 4000391 4000221 4000152 4000482 4000139 4000155 4000165 4000327 4000181 4000174 4000304 4000198 4000177 4000162 4000176 4000178 4000206 4000187 4000238 4000171 4000159 4000170 4000292 4000191 4000188 4000193 4000222 4000192 4000250 4000207 4000182 4000200 4000214 4000236 4000215 4000285 4000230 4000239 4000212 4000260 4000271 4000263 4000231 4000284 4000220 4000248 4000225 4000307 4000245 4000295 4000240 4000253 4000274 4000204 4000246 4000258 4000232 4000259 4000264 4000315 4000275 4000344 4000270 4000308 4000265 4000289 4000278 4000362 4000302 4000329 4000277 4000261 4000291 4000340 4000313 4000325 4000293 4000319 4000309 4000306 4000332 4000252 4000467 4000311 4000326 4000445 4000330 4000440 4000426 4000310 4000322 4000318 4000359 4000363 4000404 4000351 4000687 4000380 4000388 4000355 4000352 4000357 4000403 4000425 4000361 4000349 4000369 4000383 4000371 4000251 4000429 4000368 4000434 4000405 4000489 4000484A 4000384 4000443 4000377 4000406 4000323 4000387 4000424 4000593 4000532 4000414 4000517 400438 4000432 4000444 4000456 40007060007 4000435 4000431 4000439 4000441 4000446 4000490 4000448 4000450 4000452 4000499 4000453 4000460 4000636 4000626 400054 4000470 4000480 4000596 4000520 4000474 4000486 4000496 4000574 4000502 4000531 4000565 4000513 4000433 4000501 4000506 4000476 4000507 4000508 4000526 4000528 4000521 4000523 4000589 4000522 4000534 4000588 4000525 4000541 4000535 4000542 4000556 4000546 4000538 4000553 4000634 4000561 4000558 4000564 4000575 4000509 4000598 4000569 4000577 4000586 4000579 4000633 4000587 4000563 4000624 4000642 4000590 4000580 4000578 4000599 4000605 4000597 4000594 4000616 4000609 4000603 4000615 4000644 4000611 4000610 4000619 4000608 4000622 4000623 4000628 4000625 4000629 4000632 4000685 4000630 4000658 4000654 4000635 4000657 4000659 4000649 4000646 4000661 4000650 4000656 4000660 4000653 4000668 4000666 4000684 4000677 4000670 4000671 4000673 4000680 4000695 4000697 4000201 4000527 4000543 5000916

Distribution pattern

Domestic distribution nationwide. Foreign distribution worldwide.

device · product 2 of 3

BrightView X, Gamma Camera, Product Code 882478

Z-0678-2024
Recall number
Z-0678-2024
Initiated
November 30, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America
Quantity
59 US; 59 OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.

Code information

No UDI Serial numbers 11000072 11000116 11000007 11000010 11340001 11000027 11000032 4000570 11000041 11000092 11000113 11340003 11000044 11000006 11000033 11000025 11000105 11000016 11000003 11000018 11000065 11000047 11000066 11000101 11000107 11000090 11000029 11000056 11000026 11000046 11000051 11000078 11000114 11000067 11000050 11000084 11000068 11000052 11000057 11000055 11000070 11000088 11000023 11000061 11000060 11000095 11000094 11000102 11000054 11340004 11000091 11000083 11000098 11000063 11000013 11000015 11000062 11000035 11000081 11000009 11000017 11000110 11000004 11000008 11000005 11000020 11000011 11000014 11000012 11000019 11000022 11000031 11000024 11000034 11000036 11000028 11000030 11340002 11000042 11000037 11000080 11000079 11000039 11000040 11000069 11000038 11000045 11000086 11000049 11000043 11000048 11000059 11000058 11000097 11000096 11000073 11000074 11000071 11000064 11000075 11340005 11000077 11000076 11000089 11000087 11000085 11000106 11000100 11000093 11000104 11000099 11000103 11000115 11000112 11000109 11000117 11000108 11000118

Distribution pattern

Domestic distribution nationwide. Foreign distribution worldwide.

device · product 3 of 3

BrightView XCT, Gamma Camera, Product Code 882482

Z-0679-2024
Recall number
Z-0679-2024
Initiated
November 30, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America
Quantity
135 US; 294 OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.

Code information

No UDI Serial numbers 7811_12 6000374 6000199 6000219 6000012 6000123 6000065 6000051 6000084 6000351 6000259 6000212 6000337 6000302 6000144 6000193 6000068 6000075 6000385 6000027 6000124 600009 6000176 6000260 6000298 6000189 6000040 6000140 6000146 6000197 6000408 6000401 6000104 6000289 6000306 6000304 6000022 6000015 6000163 11000021 6000325 6000021 6000056 6000060 6000057 6000026 6000054 6000033 6000089 6000094 6000053 6000082 6000165 6000164 6000167 6000194 6000171 6000203 6000195 6000204 6000220 6000229 6000228 6000237 6000235 6000206 6000295 6000318 6000317 6000349 6000352 6000355 6000396 6000391 6000402 6000020 6000037 6000047 6000077 6000130 6000147 6000128 6000184 6000131 6000132 6000210 6000251 6000269 6000310 6000309 6000416 6000338 6000330 6000339 6000109 6000115 6000126 6000276 6000025 6000029 6000036 6000013 6000038 6000045 6000173 6000006 6000083 6000081 6000086 6000215 6000074 6000113 6000072 6000078 6000090 6000070 6000186 6000188 6000185 6000174 6000127 6000159 6000182 6000183 6000201 6000187 6000236 6000234 6000246 6000296 6000334 6000332 6000368 6000370 6000380 6000035 6000111 6000059 6000097 6000192 6000258 6000278 6000376 6000379 6000363 6000406 6000121 6000129 6000145 6000156 6000233 6000211 6000240 6000224 6000271 6000303 6000300 6000320 6000319 6000367 6000407 6000333 6000389 6000342 6000041 6000262 6000307 6000293 6000329 6000354 6000005 6000010 6000049 6000103 6000066 6000105 6000181 6000202 6000222 6000265 6000336 6000371 6000216 6000255 11000082 6000241 6000290 6000292 6000291 6000096 6000098 6000254 6000257 6000270 6000230 6000274 6000062 6000064 6000100 6000101 6000133 6000238 6000190 6000227 6000248 6000384 6000400 6000398 6000085 6000088 6000080 6000073 6000244 6000118 6000151 6000136 6000231 6000180 6000369 6000346 6000032 6000141 6000067 6000226 6000321 6000273 6000061 6000048 6000055 6000125 6000168 6000166 6000169 6000205 6000280 6000281 6000341 6000350 6000358 6000359 6000362 6000365 6000427 6000421 6000418 6000155 6000157 6000326 6000249 6000044 5340007 6000120 6000315 6000099 6000079 6000299 6000139 6000017 6000247 6000426 6000102 6340008 6000347 6000410 6000414 6000043 6000039 6340010 6000305 6000223 6000252 6000268 6000267 6000264 6000294 6000323 6000343 6000392 6000428 6000138 6000154 6000242 6000243 6000314 6000424 6000425 6000423 6000413 6000200 6000357 6000328 6000050 6000297 6000261 6000282 6000415 6000119 6000221 6000375 6000152 6340009 6000011 6000024 6000175 6000031 6000253 6000042 6000052 6000030 6000002 6000004 6000069 6000005A 6000076 6000142 6000004A 6000122 6000016 6000158 6000095 6000092 6000019 6000023 6000028 6000114 6000003 6000110 6000058 6000162 6000018 6000071 6000063 6000091 6000106 6000286 6000107 6000117 6000087 6000134 6000116 6000218 6000148 6000108 6000143 6000150 6000277 6000112 6000208 6000209 6000288 6000160 6000161 6000135 6000361 6000191 6000149 6000153 6000177 6000225 6000170 6000196 6000172 6000178 6000405 6000353 6000214 6000198 6000213 6000179 6000360 6000217 6000412 6000272 6000250 6000331 6000287 6000232 6000239 6000283 6000245 6340011 6000266 6000285 6000263 6000284 6000345 6000279 6000312 6000311 6000275 6000335 6000356 6000344 6000364 6000308 11000111 6000316 6000313 6000327 6000324 6000322 6000377 6000403 6000348 6000378 6000383 6000366 6000404 6000411 6000393 6000381 6000420 6000387 6000340 6000422 6000373 6000372 6000417 6000388 6000390 6000382 6000399 6000394 6000395 6000386 6000409 6000419 6000301 6000207

Distribution pattern

Domestic distribution nationwide. Foreign distribution worldwide.