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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76716

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

Open FDA event record

Event summary

Timeline bucket
February 24, 2017
Product types
Device
Classifications
Class II and Class III
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

4 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 4

BrightView SPECT model number 882480 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-1750-2017
Recall number
Z-1750-2017
Initiated
February 24, 2017
Classification
Class II
Status
Terminated
Quantity
84 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.

Code information

4000008, 4000287, 4000497, 4000364, 4000346, 4000557, 4000423, 4000088, 4000029, 4000631, 4000339 , 4000072, 4000643, 4000640, 4000420, 4000543, 4000010, 4000282, 4000216, 4000415, 4000208, 4000322, 4000406, 4000434, 4000241, 4000055, 4000117, 4000200, 4000138, 4000352, 4000509, 4000362, 4000598, 4000433, 4000178, 4000473, 4000271, 4000357, 4000258, 4000060, 4000528, 4000099, 4000192, 4000079, 40000101, 4000310, 4000214, 4000671, 4000050, 4000349, 4000658, 4000308, 4000215, 4000384, 4000263, 4000074, 4000255, 4000633, 4000098A, 4000251, 4000446, 4000680, 4000095, 4000424, 4000508, 4000603, 4000347, 4000113, 4000668, 4000703001, 4000140, 4000367, 4000037, 4000426, 4000440, 4000391, 4000177, 4000482, 4000162, 4000083, 4000501, 4000505, 4000317, 4000174

Distribution pattern

Worldwide distribution - US including AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, TN, TX, VA, WA, WI, and WV. Internationally to Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Egypt, France, Germany, India, Israel, Italy, Japan, Mexico, Republic of Korea, Malaysia Netherlands, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, UAE, and UK. There are eleven (11) government accounts for this recall: Edward Hines Jr VA Hospital, 5th Ave & Roosevelt Rd, Hines, IL 60141; VA Jessie Brown OPC, 2030 W Taylor St, Chicago, IL 60612; VA Medical Center, 4300 W 7th St, Little Rock, AR 72205; VA Medical Center, 2200 SW Gage Blvd, Topeka, KS 66622; VA Medical Center, 2501 W 22nd St, Sioux Falls, SD 57105; VA Medical Center, 3600 30th St, Des Moines, IA 50310; VA Medical Center, 2300 Ramsey St, Fayetteville, NC 28301; VA Medical Center Durham, 508 Fulton St, Durham, NC 27705; VA Medical Center of Orlando, 13800 Veterans Way, Orlando, FL 32827; Veterans Hospital, 1 Veterans Dr, Minneapolis, MN 55417; Womack Army Medical Center, Reilly Rd, Fort Bragg, NC 28307. There are thirteen (13) Canada accounts for this recall: CAMPHILL SITE, 1796 SUMMER ST, HALIFAX, NOVA SCOTIA B3H 3A7; COR CARE INC, 325 MILNER AVE STE 410, SCARBOROUGH, ONTARIO M1B 5N1; CSSS DE RIMOUSKI-NEIGETTE, ROUL¿AU 150, RIMOUSKI, QUEBEC G5L 5T1; FOOTHILLS MEDICAL CENTRE, 1403 29 ST NW, CALGARY, ALBERTA T2N 2T9; HEADWATERS HEALTH CENTRE, 100 ROLLING HILLS DR, ORANGEVILLE, ONTARIO L9W 4X9; HEALTH SCIENCES NORTH, 41 RAMSEY LAKE RD, SUDBURY, ONTARIO P3E 5J1; MEDICAL IMAGING CONSULTAN, 200 BOUDREAU RD STE 102 ST., ALBERT, ALBERTA T8N 6B9; NORTH BAY REGIONAL HEALTH, 50 COLLEGE DR, NORTH BAY, ONTARIO P1B 0A4; PETERBOROUGH REGIONAL HEA, 1 HOSPITAL DR, PETERBOROUGH, ONTARIO K9J 7C6; ROCKY VIEW GENERAL HOSPIT, 7007 14 ST SW, CALGARY, ALBERTA T2V 1P9; ROYAL VICTORIA HEALTH CEN, 201 GEORGIAN DR, BARRIE, ONTARIO L4M 6M2; SOUTHERN ALBERTA INS. TEC, 1301 16 AVE NW, CALGARY, ALBERTA T2M 0L4; WOODSTOCK HOSPITAL, 310 JULIANA DR, WOODSTOCK, ONTARIO N4V 0A4. There is one (1) Mexico account for this recall: Arrendadora Medica Galena, AV Tulum#MZ 1LT 1#SM 12, Benito Juarez, Quintana Roo, 77505.

device · product 2 of 4

BrightView XCT model number 882482 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). 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-1751-2017
Recall number
Z-1751-2017
Initiated
February 24, 2017
Classification
Class II
Status
Terminated
Quantity
90 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.

Code information

6000203, 6000396, 6000229, 6000195, 6000204, 6000402, 6000237, 6000093, 6000206, 6000022, 6000416, 6000330, 6000130, 6000339, 6000276, 6000086, 6000051, 6000351, 6000188, 6000065, 6000380, 6000013, 6000090, 6000370, 6000025, 6000236, 6000129, 6000121, 6000342, 6000367, 6000256, 6000101, 6000400, 6000371, 6000336, 6000168 , 6000418, 6000359, 6000421, 6000120, 6000299, 6000046, 6340010, 6000252, 6000428, 6000413, 6000230, 6000049, 6000231,, 6000151, 6000369, 6000244, 6000403, 6000405, 6000143, 6000110, 6000285, 6000312, 6000160, 6000344, 6000394, 6000283, 6000388, 6000146, 6000232, 6000335, 6000356, 6000140, 6000401, 6000408, 6340011, 6000348, 6000277, 6000245, 6000419, 6000177, 6000386, 6000390, 6000360, 6000114, 6000028, 6000042, 6000382, 6000275, 6000024, 6000002, 6000311, 6000213, 6000062, 6000363

Distribution pattern

Worldwide distribution - US including AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, TN, TX, VA, WA, WI, and WV. Internationally to Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Egypt, France, Germany, India, Israel, Italy, Japan, Mexico, Republic of Korea, Malaysia Netherlands, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, UAE, and UK. There are eleven (11) government accounts for this recall: Edward Hines Jr VA Hospital, 5th Ave & Roosevelt Rd, Hines, IL 60141; VA Jessie Brown OPC, 2030 W Taylor St, Chicago, IL 60612; VA Medical Center, 4300 W 7th St, Little Rock, AR 72205; VA Medical Center, 2200 SW Gage Blvd, Topeka, KS 66622; VA Medical Center, 2501 W 22nd St, Sioux Falls, SD 57105; VA Medical Center, 3600 30th St, Des Moines, IA 50310; VA Medical Center, 2300 Ramsey St, Fayetteville, NC 28301; VA Medical Center Durham, 508 Fulton St, Durham, NC 27705; VA Medical Center of Orlando, 13800 Veterans Way, Orlando, FL 32827; Veterans Hospital, 1 Veterans Dr, Minneapolis, MN 55417; Womack Army Medical Center, Reilly Rd, Fort Bragg, NC 28307. There are thirteen (13) Canada accounts for this recall: CAMPHILL SITE, 1796 SUMMER ST, HALIFAX, NOVA SCOTIA B3H 3A7; COR CARE INC, 325 MILNER AVE STE 410, SCARBOROUGH, ONTARIO M1B 5N1; CSSS DE RIMOUSKI-NEIGETTE, ROUL¿AU 150, RIMOUSKI, QUEBEC G5L 5T1; FOOTHILLS MEDICAL CENTRE, 1403 29 ST NW, CALGARY, ALBERTA T2N 2T9; HEADWATERS HEALTH CENTRE, 100 ROLLING HILLS DR, ORANGEVILLE, ONTARIO L9W 4X9; HEALTH SCIENCES NORTH, 41 RAMSEY LAKE RD, SUDBURY, ONTARIO P3E 5J1; MEDICAL IMAGING CONSULTAN, 200 BOUDREAU RD STE 102 ST., ALBERT, ALBERTA T8N 6B9; NORTH BAY REGIONAL HEALTH, 50 COLLEGE DR, NORTH BAY, ONTARIO P1B 0A4; PETERBOROUGH REGIONAL HEA, 1 HOSPITAL DR, PETERBOROUGH, ONTARIO K9J 7C6; ROCKY VIEW GENERAL HOSPIT, 7007 14 ST SW, CALGARY, ALBERTA T2V 1P9; ROYAL VICTORIA HEALTH CEN, 201 GEORGIAN DR, BARRIE, ONTARIO L4M 6M2; SOUTHERN ALBERTA INS. TEC, 1301 16 AVE NW, CALGARY, ALBERTA T2M 0L4; WOODSTOCK HOSPITAL, 310 JULIANA DR, WOODSTOCK, ONTARIO N4V 0A4. There is one (1) Mexico account for this recall: Arrendadora Medica Galena, AV Tulum#MZ 1LT 1#SM 12, Benito Juarez, Quintana Roo, 77505.

device · product 3 of 4

BrightView X 3/4 model number 882479 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). 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-1752-2017
Recall number
Z-1752-2017
Initiated
February 24, 2017
Classification
Class II
Status
Terminated
Quantity
0

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.

Code information

None

Distribution pattern

Worldwide distribution - US including AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, TN, TX, VA, WA, WI, and WV. Internationally to Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Egypt, France, Germany, India, Israel, Italy, Japan, Mexico, Republic of Korea, Malaysia Netherlands, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, UAE, and UK. There are eleven (11) government accounts for this recall: Edward Hines Jr VA Hospital, 5th Ave & Roosevelt Rd, Hines, IL 60141; VA Jessie Brown OPC, 2030 W Taylor St, Chicago, IL 60612; VA Medical Center, 4300 W 7th St, Little Rock, AR 72205; VA Medical Center, 2200 SW Gage Blvd, Topeka, KS 66622; VA Medical Center, 2501 W 22nd St, Sioux Falls, SD 57105; VA Medical Center, 3600 30th St, Des Moines, IA 50310; VA Medical Center, 2300 Ramsey St, Fayetteville, NC 28301; VA Medical Center Durham, 508 Fulton St, Durham, NC 27705; VA Medical Center of Orlando, 13800 Veterans Way, Orlando, FL 32827; Veterans Hospital, 1 Veterans Dr, Minneapolis, MN 55417; Womack Army Medical Center, Reilly Rd, Fort Bragg, NC 28307. There are thirteen (13) Canada accounts for this recall: CAMPHILL SITE, 1796 SUMMER ST, HALIFAX, NOVA SCOTIA B3H 3A7; COR CARE INC, 325 MILNER AVE STE 410, SCARBOROUGH, ONTARIO M1B 5N1; CSSS DE RIMOUSKI-NEIGETTE, ROUL¿AU 150, RIMOUSKI, QUEBEC G5L 5T1; FOOTHILLS MEDICAL CENTRE, 1403 29 ST NW, CALGARY, ALBERTA T2N 2T9; HEADWATERS HEALTH CENTRE, 100 ROLLING HILLS DR, ORANGEVILLE, ONTARIO L9W 4X9; HEALTH SCIENCES NORTH, 41 RAMSEY LAKE RD, SUDBURY, ONTARIO P3E 5J1; MEDICAL IMAGING CONSULTAN, 200 BOUDREAU RD STE 102 ST., ALBERT, ALBERTA T8N 6B9; NORTH BAY REGIONAL HEALTH, 50 COLLEGE DR, NORTH BAY, ONTARIO P1B 0A4; PETERBOROUGH REGIONAL HEA, 1 HOSPITAL DR, PETERBOROUGH, ONTARIO K9J 7C6; ROCKY VIEW GENERAL HOSPIT, 7007 14 ST SW, CALGARY, ALBERTA T2V 1P9; ROYAL VICTORIA HEALTH CEN, 201 GEORGIAN DR, BARRIE, ONTARIO L4M 6M2; SOUTHERN ALBERTA INS. TEC, 1301 16 AVE NW, CALGARY, ALBERTA T2M 0L4; WOODSTOCK HOSPITAL, 310 JULIANA DR, WOODSTOCK, ONTARIO N4V 0A4. There is one (1) Mexico account for this recall: Arrendadora Medica Galena, AV Tulum#MZ 1LT 1#SM 12, Benito Juarez, Quintana Roo, 77505.

device · product 4 of 4

BrightView X 3/8 model number 882478 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). 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-1753-2017
Recall number
Z-1753-2017
Initiated
February 24, 2017
Classification
Class III
Status
Terminated
Quantity
27 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.

Code information

11000105, 11000116, 11000018, 11000047, 11000046, 11000010, 11000068, 11000098, 11000083, 11000013, 11000107, 11000056, 11000042, 11000093, 11000089, 11000104, 11000077, 11000028, 11000085, 11000040, 11000076, 11000117, 11000058, 11000118, 11000086, 11340005, 11000064

Distribution pattern

Worldwide distribution - US including AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, TN, TX, VA, WA, WI, and WV. Internationally to Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Egypt, France, Germany, India, Israel, Italy, Japan, Mexico, Republic of Korea, Malaysia Netherlands, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, UAE, and UK. There are eleven (11) government accounts for this recall: Edward Hines Jr VA Hospital, 5th Ave & Roosevelt Rd, Hines, IL 60141; VA Jessie Brown OPC, 2030 W Taylor St, Chicago, IL 60612; VA Medical Center, 4300 W 7th St, Little Rock, AR 72205; VA Medical Center, 2200 SW Gage Blvd, Topeka, KS 66622; VA Medical Center, 2501 W 22nd St, Sioux Falls, SD 57105; VA Medical Center, 3600 30th St, Des Moines, IA 50310; VA Medical Center, 2300 Ramsey St, Fayetteville, NC 28301; VA Medical Center Durham, 508 Fulton St, Durham, NC 27705; VA Medical Center of Orlando, 13800 Veterans Way, Orlando, FL 32827; Veterans Hospital, 1 Veterans Dr, Minneapolis, MN 55417; Womack Army Medical Center, Reilly Rd, Fort Bragg, NC 28307. There are thirteen (13) Canada accounts for this recall: CAMPHILL SITE, 1796 SUMMER ST, HALIFAX, NOVA SCOTIA B3H 3A7; COR CARE INC, 325 MILNER AVE STE 410, SCARBOROUGH, ONTARIO M1B 5N1; CSSS DE RIMOUSKI-NEIGETTE, ROUL¿AU 150, RIMOUSKI, QUEBEC G5L 5T1; FOOTHILLS MEDICAL CENTRE, 1403 29 ST NW, CALGARY, ALBERTA T2N 2T9; HEADWATERS HEALTH CENTRE, 100 ROLLING HILLS DR, ORANGEVILLE, ONTARIO L9W 4X9; HEALTH SCIENCES NORTH, 41 RAMSEY LAKE RD, SUDBURY, ONTARIO P3E 5J1; MEDICAL IMAGING CONSULTAN, 200 BOUDREAU RD STE 102 ST., ALBERT, ALBERTA T8N 6B9; NORTH BAY REGIONAL HEALTH, 50 COLLEGE DR, NORTH BAY, ONTARIO P1B 0A4; PETERBOROUGH REGIONAL HEA, 1 HOSPITAL DR, PETERBOROUGH, ONTARIO K9J 7C6; ROCKY VIEW GENERAL HOSPIT, 7007 14 ST SW, CALGARY, ALBERTA T2V 1P9; ROYAL VICTORIA HEALTH CEN, 201 GEORGIAN DR, BARRIE, ONTARIO L4M 6M2; SOUTHERN ALBERTA INS. TEC, 1301 16 AVE NW, CALGARY, ALBERTA T2M 0L4; WOODSTOCK HOSPITAL, 310 JULIANA DR, WOODSTOCK, ONTARIO N4V 0A4. There is one (1) Mexico account for this recall: Arrendadora Medica Galena, AV Tulum#MZ 1LT 1#SM 12, Benito Juarez, Quintana Roo, 77505.