MEDRAD Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous
FDA device recall Z-1686-2015 · posted 2015-05-28 · Terminated
Recall details
- Recalling firm
- Medrad Inc dba Bayer R&I
- Reason for recall
- The root cause investigation showed that the under-volume hazard can occur when the unit has been configured to prime with contrast, but instead primes with saline due to the configuration data not being sent to the injector head. This may create a non-optimal priming condition that could lead to under-infusion.
- Action taken
- Bayer Healthcare sent a Medical Device Field Corrective Action letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify any affected device. Bayer Service will schedule time to update their software free of charge. Customers with questions were instructed to contact the customer support team at 1-800-633-7237. For questions regarding this recall call 412-767-2400.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 133
- Distribution
- Nationwide Distribution
- Date initiated
- 2013-09-20
- Date posted
- 2015-05-28
- Date terminated
- 2015-06-16
- Location
- Indianola, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC (K082905) | Medrad, Inc. | 2009-01-12 |