Power cord for QVue Continuous Cardiac Output (CCO)/SO2 computer, list #s 52230-04-03, 52230-04-05, 52230-04-07, 52230-0
FDA device recall Z-0147-2010 · posted 2009-11-09 · Terminated
Recall details
- Recalling firm
- Hospira Inc
- Reason for recall
- Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Action taken
- Hospira initiated its recall on 08/14/2009. A nationwide press release was issued to AP, and a letter to consignees was sent via UPS. The firm will replace affected cords and effectiveness checks will be conducted through tracking of servicing.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- dxg
- Quantity affected
- 204,999 power cords distributed for all devices
- Distribution
- Worldwide distribution.
- Date initiated
- 2009-08-11
- Date posted
- 2009-11-09
- Date terminated
- 2012-04-04
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONTINUOUS CARDIAC OUTPUT SYSTEM (K932414) | Abbott Laboratories | 1994-11-14 |