CLASS II Device recall · Reported 12 Apr 2017 · FDA Enforcement Report
BrightView XCT recalled by Philips Medical Systems
Philips Medical Systems (Cleveland) is recalling BrightView XCT, distributed nationwide in the US. The recall was initiated on 24 Feb 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1751-2017
- FDA event ID
- 76716
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Feb 2017
- FDA classified
- 6 Apr 2017
- Reported
- 12 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 24 Feb 2017 | Recall initiated by company | |
| 6 Apr 2017 | Classified by FDA | +41 days |
| 12 Apr 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide ArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouriMississippi
Questions about this recall
Is BrightView XCT recalled?
Yes. Philips Medical Systems (Cleveland) recalled BrightView XCT on 24 Feb 2017. The recall is Class II and its status is Terminated. Recall number Z-1751-2017.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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