Z-0089-06

Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545...

Name: Z-0089-06 Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545...
Creator: Medrad Inc
Published: 2005-10-07
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2005-10-07 / Terminated

FDA source

Medrad Inc began a recall of Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545, 3010546, 3010547, 3010548, 3010549, 3010550... on 2005-10-07. The reason FDA records is "overhead system can fall due to the failure of a retaining ring". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0089-06
Status: Terminated
Initiated: 2005-10-07
Posted: 2005-10-25
Terminated: 2007-11-29
Recalling firm: Medrad, Inc.
Product: Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545, 3010546, 3010547, 3010548, 3010549, 3010550, 3010551, 3010552, and 3010553.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: overhead system can fall due to the failure of a retaining ring.
FDA 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 in commerce: 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, Singapore, Taiwan, Brazil, Columbia, Cuba, Mexico, and Japan.
Product codes and lots: All serial numbers

Product code JAK

K944983Class IIMedrad Counterpoise SystemMedrad, Inc. / cleared 1994-11-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)