Xcelera R1.2 Cardiology image and information management solution software.
FDA device recall Z-0640-05 · posted 2005-03-18 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Reason for recall
- Loss of image data from image repository and archive requiring patients to undergo repeat imaging.
- Action taken
- The firm notified hospitals via letter sent 12/21/2004 stating the service organization will perform onsite upgrades.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 33
- Distribution
- Hospitals and medical centers throughout the US.
- Date initiated
- 2004-12-21
- Date posted
- 2005-03-18
- Date terminated
- 2006-02-10
- Location
- Bothell, WA
Monitor recalls programmatically
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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 |