Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips
FDA device recall Z-1074-2014 · posted 2014-02-24 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Three problems were reported to the firm: When positioning for a relative 180 degree non circular acquisition the second (bottom) detector was not positioned correctly causing an inappropriate rotation orbit calculation. When the acquisition was started and the detectors began to move into position, the incorrect calculation resulted in the detectors coming in contact with the patient. As
- Action taken
- On 12/19/2013 the firm sent Field Safety Notices to their customers.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 1,143 units
- Distribution
- Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MI, MN, MO, MS, MT, NC, ND, NE, N
- Date initiated
- 2013-12-19
- Date posted
- 2014-02-24
- Date terminated
- 2015-01-12
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRIGHTVIEW VCT IMAGING SYSTEM (K080927) | Philips Medical Systems (Cleveland), Inc. | 2008-04-11 |