Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545, 3010546, 301
FDA device recall Z-0089-06 · posted 2005-10-25 · Terminated
Recall details
- Recalling firm
- Medrad Inc
- Reason for recall
- overhead system can fall due to the failure of a retaining ring.
- Action taken
- The recalling firm issued an Urgent Medical Device Field Correction notice dated 10/7/05 to all customers. The notice informs customers of the problem and cautions anyone to be under the system when in use. The notice also informs the customer that a firm representative will schedule a time to perform the upgrade. On 10/13/05, the recalling firm also issued a notification to scanner manufacturers alerting them of the problem.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 2080 units
- Distribution
- The product was shipped to medical facilities nationwide. The product was also shipped to Austria, Belgium, Chile, Czech, Denmark, Spain, Finland, France, Great Britain, Ireland, Israel, Italy, Nether
- Date initiated
- 2005-10-07
- Date posted
- 2005-10-25
- Date terminated
- 2007-11-29
- Location
- Indianola, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDRAD COUNTERPOISE SYSTEM (K944983) | Medrad, Inc. | 1994-11-29 |