FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light
- Recall number
- Z-0515-2013
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light
- Status
- Terminated
- Initiated
- 2012-10-10
- Posted
- 2012-12-12
- Terminated
- 2014-11-06
- Reason
- A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems.
- Root cause
- Equipment maintenance
- Action
- 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.
- Quantity
- 1315
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Part numbers 7721165, 4787714, 7559375, 10281150, 10281151, 10281152 and 10281183
- 510(k) numbers
- ["K063333"]
- PMA numbers
- not on file
- Product code
- FSY
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28