Xcelera System, image processing, radiological.
FDA device recall Z-0973-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Reason for recall
- Potential for the image data to be erased from the long term archive.
- Action taken
- On 4/15/04 the firm sent letters to customers advising of the problem and that a service representative will visit and conduct a software upgrade.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 56 units
- Distribution
- Devices were distributed to hospitals and medical centers throughout the US.
- Date initiated
- 2004-04-15
- Date posted
- 2004-07-20
- Date terminated
- 2005-04-11
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS HARMONY RELEASE 1 (K022788) | Philips Medical Systems North America Co. | 2002-10-25 |