Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545, 3010546, 3010547, 3010548, 3010549, 3010550, 3010551, 3010552, and 3010553.
This recall has been terminated (originally issued October 25, 2005).
- Company
- Medrad Inc
- Recall Initiated
- October 7, 2005
- Posted
- October 25, 2005
- Terminated
- November 29, 2007
- Recall Number
- Z-0089-06
- Quantity
- 2080 units
- Firm Location
- Indianola, PA
- Official Source
- View on FDA website ↗
Reason for Recall
overhead system can fall due to the failure of a retaining ring.
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, Singapore, Taiwan, Brazil, Columbia, Cuba, Mexico, and Japan.
Lot / Code Info
All serial numbers
Root Cause
Other
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.