Recall Z-0089-06 ยท JAK System, X-Ray, Tomography, Computed
Medrad Inc
Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545, 3010546, 3010547, 3010548, 3010549, 3010550, 3010551, 3010552, and 3010553.
| Date | Oct 25, 2005 (initiated Oct 7, 2005) |
| Status | Terminated |
| Reason | overhead system can fall due to the failure of a retaining ring. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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, Netherlands, Norway, Sweden, Austrailia, Kuwait, Saudia Arabia, Canada, China, Hong Kong, India, Korea, Si |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944983 | MEDRAD COUNTERPOISE SYSTEM Medrad, Inc., Nov 29, 1994 |