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U.S. Department of Health and Human Services

Class 2 Device Recall Medrad Overhead Couterpoise System II

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 Class 2 Device Recall Medrad Overhead Couterpoise System IIsee related information
Date Initiated by FirmOctober 07, 2005
Date PostedOctober 25, 2005
Recall Status1 Terminated 3 on November 29, 2007
Recall NumberZ-0089-06
Recall Event ID 33816
510(K)NumberK944983 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
ProductMedrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545, 3010546, 3010547, 3010548, 3010549, 3010550, 3010551, 3010552, and 3010553.
Code Information All serial numbers
FEI Number 2520313
Recalling Firm/
Manufacturer		 Medrad Inc
1 Medrad Dr
Indianola PA 15051-9759
For Additional Information ContactLaurence R. Kopyta
412-767-2400 Ext. 3621
Manufacturer Reason
for Recall		overhead system can fall due to the failure of a retaining ring.
FDA Determined
Cause 2		Other
ActionThe 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 in Commerce2080 units
DistributionThe 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAK
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