OptiVantage DH Power Injection System.
FDA device recall Z-0288-2007 · posted 2006-12-16 · Terminated
Recall details
- Recalling firm
- Mallinckrodt Inc
- Reason for recall
- The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will always inject in accordance with the parameters shown on the power head. If this lack of synchronization occurs and is not noticed by the clinican, contrast would be injected at a higher or lower flow rate than desired.
- Action taken
- The recalling firm sent a letter dated 11/7/2006 to all consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- CXT
- Quantity affected
- 1348 devices.
- Distribution
- Worldwide distribution ---- including USA and countries of Australia, Belgium, Brazil, Canada, Chile, Columbia, Denmark, Mexico, Panama, Puerto Rico, Singapore and South Africa.
- Date initiated
- 2006-11-07
- Date posted
- 2006-12-16
- Date terminated
- 2007-07-21
- Location
- Cincinnati, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTIV ANTAGE DH POWER INJECTION SYSTEM (K042744) | Mallinckrodt Inc., Liebel-Flarsheim Business | 2004-11-30 |