BrightView XCT
Medical device recall Z-1751-2017. Published in FDA’s Enforcement Report on Apr 12, 2017.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 12, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 29 states named in where it went
- 90 systems how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
90 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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,…
Every code shown here, 810 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
29 states and territories.
Every one of them
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- New Jersey
- New York
- Ohio
- Oregon
- Pennsylvania
- Tennessee
- Texas
- Virginia
- Washington
- Wisconsin
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 24, 2017.
- FDA classified it on Apr 6, 2017.
- FDA’s Enforcement Report published it on Apr 12, 2017.
- FDA terminated it on Jul 2, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Medical Systems (Cleveland) Inc, of Cleveland, OH.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.