FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA Inc.: Siemens Biograph mCT-S 64, model number 10248672. Medical Imaging Equipment.
- Recall number
- Z-0164-2010
- Recalling firm
- Siemens Medical Solutions USA Inc.
- Product
- Siemens Biograph mCT-S 64, model number 10248672. Medical Imaging Equipment.
- Status
- Terminated
- Initiated
- 2009-08-11
- Posted
- 2009-11-10
- Terminated
- 2009-12-22
- Reason
- In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly.
- Root cause
- Device Design
- Action
- Siemens Medical Solutions USA, Inc. issued an "Urgent Field Correction - Recall" notice to consignees by letter dated September 3, 2009 informing them of the problem and that a Siemens service representative will be in contact shortly to service the affected product. For further information, contact Siemens at 1-800-888-7436.
- Quantity
- 2 units
- Distribution
- Worldwide Distribution -- United States (IL and OH), Germany, France and Hong Kong.
- Lot, serial or model codes
- serial numbers: 1002 and 1003
- 510(k) numbers
- ["K060631"]
- 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