FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM CT System Sensation Cardiac (+ Straton), Computed Tomography X-Ray System, Model Numbers 75 43 106
- Recall number
- Z-0161-05
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM CT System Sensation Cardiac (+ Straton), Computed Tomography X-Ray System, Model Numbers 75 43 106
- Status
- Terminated
- Initiated
- 2004-09-28
- Posted
- 2004-11-03
- Terminated
- 2008-09-04
- Reason
- Calcium Scoring feature on this devices is not closing properly after patient's exams.
- Root cause
- Other
- Action
- The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.
- Quantity
- 47 units
- Distribution
- The product was shipped to medical facilities nationwide and government account in IL.
- Lot, serial or model codes
- Serial Numbers: 52948, 52950, 52951, 52952, 52953, 52954, 52955, 52956, 52957, 52958, 52959, 52960, 52961, 52962, 52963, 52964, 52965, 52966, 52967, 52968, 52969, 52971, 52972, 52973, 52974, 52975, 52976, 52977, 52978, 52979, 52980, 52981, 52982, 52983, 52984, 52985, 52986, 52988, 52989, 58990, 52991, 52992, 52993, 52994, 52996, 52997, and 58999
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JAK
- 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