Philips Odyssey VP Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.
FDA device recall Z-0093-04 · posted 2003-11-06 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Due to a software anomaly, an incorrect patient name may be transmitted with image to Odyssey workstation.
- Action taken
- The firm notified their affected consignees by letter on 9/15/2003. The customers were informed how to avoid the problem until a software upgrade is installed on the units.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 1,334 units installed
- Distribution
- The systems were installed at medical facilities located nationwide and worldwide.
- Date initiated
- 2003-09-15
- Date posted
- 2003-11-06
- Date terminated
- 2008-10-29
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ODYSSEY LX, MODEL 211320 (K003437) | Philips Medical Systems (Cleveland), Inc. | 2001-02-02 |
| PRISM XPVT SYSTEM (210823) (K964712) | Philips Medical Systems (Cleveland), Inc. | 1997-02-21 |