MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light
FDA device recall Z-0515-2013 · posted 2012-12-12 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems.
- Action taken
- Siemens sent a Customer Safety Advisory Notice on October 3, 2012, to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were reminded that they should contact the service department in the event of damage or other irregularity. Customers were instructed to forward the information contained in the notice to their employees responsible for the operation of the affected product. Customers were also asked to forward the safety information to other organization affected by the product and to any users of the product. For questions regarding this recall call 610-219-4834.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- FSY
- Quantity affected
- 1315
- Distribution
- Nationwide Distribution
- Date initiated
- 2012-10-10
- Date posted
- 2012-12-12
- Date terminated
- 2014-11-06
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| M3 (K063333) | Mavig GmbH | 2006-11-21 |