Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Al
FDA device recall Z-0181-2015 · posted 2014-11-07 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.
- Action taken
- Philips Medical Systems issued certified letters on 7/8/14 and receipt returned for tracking purposes. A mandatory Field Change Order with reference FC072200253 is being released that requires Philips field service engineers to install Software release R8.2.0.3. If you need any further information or support concerning this issue, contact your local Philips representative: SUPPORT 1-800-722-9377.
- Root cause
- Software design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 22 systems
- Distribution
- Distributed in the states of IL, and TN, and the countries of Argentina , Australia, Belgium, Denmark, Egypt, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of Netherlands, Norway, Saudi Ar
- Date initiated
- 2014-07-08
- Date posted
- 2014-11-07
- Date terminated
- 2017-01-18
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALLURA XPER FD20 (K033737) | Philips Medical Systems North America, Inc. | 2003-12-09 |