FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA Inc.: Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302
- Recall number
- Z-2337-2015
- Recalling firm
- Siemens Medical Solutions USA Inc.
- Product
- Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302
- Status
- Terminated
- Initiated
- 2015-07-14
- Posted
- 2015-08-05
- Terminated
- 2016-03-03
- Reason
- Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.
- Root cause
- Packaging change control
- Action
- The firm initiated their recall on 07/14/2015 by telephone to the sole US consignee. The update is scheduled for 07/15/2015.
- Quantity
- 2 units
- Distribution
- Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland.
- Lot, serial or model codes
- SERIAL NUMBERS: 1041, 1042
- 510(k) numbers
- ["K123737"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1034973
- Firm city
- Knoxville
- Firm state
- TN
- 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