BrightView XCT Gamma Camera, 3/4". Philips Medical Systems, Inc. Intended to produce images depicting the anatomical dis
FDA device recall Z-2949-2011 · posted 2011-08-04 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Non-conformances with BrightView X/XCT systems running version 2.0.1 including data transfer, XCT acquisition, Pixel Mask for image reconstruction and table moving incorrectly.
- Action taken
- Philips Medical Systems, Inc. set a "Customer Information" letter dated July 8, 2011 to all affected customers. The letter informed them of an upcoming software updated (version 2.5). For questions please contact 800-722-9377 (option 5).
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 213 units
- Distribution
- Worldwide Distribution: (USA) Nationwide distribution and the countries of Greece, Australia, Belgium, China, Czech Republic, France, Germany, Indonesia, Israel, Japan, Lithuania, Malaysia, Netherland
- Date initiated
- 2011-06-15
- Date posted
- 2011-08-04
- Date terminated
- 2013-02-15
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRIGHTVIEW VCT IMAGING SYSTEM (K080927) | Philips Medical Systems (Cleveland), Inc. | 2008-04-11 |