FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: syngo MultiModality WorkPlace (MM WP). Software product(Model Number 10140720). The product is intended for use in picture archiving and communications system.
- Recall number
- Z-0324-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- syngo MultiModality WorkPlace (MM WP). Software product(Model Number 10140720). The product is intended for use in picture archiving and communications system.
- Status
- Terminated
- Initiated
- 2008-09-12
- Posted
- 2008-12-03
- Terminated
- 2009-09-23
- Reason
- Values derived from Dynamic CT data sets may be incorrect. The corresponding images are not affected.
- Root cause
- Software design
- Action
- The recalling firm has issued a software update to affected customers via Update Instructions CT034/08/S. This software update corrects the values from the volume perfusion post processing application. A firm representative will visit each consignee to install the software update beginning 9/12/08.
- Quantity
- 130 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Serial numbers: 7826, 7951, 7981, 7989, 8011, 8056, 8109, 8161, 8209, 8213, 8312, 8341, 8361, 8382, 8393, 8405, 8409, 8413, 8430, 8433, 8442, 8511, 8526, 8536, 8548, 8637, 8638, 8657, 8670, 8688, 8701, 8707, 8771, 8772, 8773, 8774, 8781, 8793, 8814, 8829, 8862, 8879, 8881, 9043, 9044, 9046, 9080, 9097, 9081, 9105, 9137, 9149, 9152, 9154, 9188, 9191, 9206, 9218, 9219, 9232, 9235, 9243, 9244, 9248, 9283, 9291, 9316, 9322, 9351, 9360, 9361, 9368, 9388, 9394, 9395, 9413, 9414, 9416, 9417, 9429, 9445, 9446, 9452, 9488, 9498, 9504, 9508, 9520, 9521, 9532, 9536, 9568, 9723, 9725, 9729, 9737, 15154, 15510, 15512, 20903, 20904, 20907, 20917, 20928, 20931, 20937, 20939, 20940, 20941, 20942, 20943, 20944, 20945, 20946, 20948, 20955, 20956, 20957, 20961, 20962, 20972, 20974, 20977, 21017, 21018, 21020, 21021, 21025, 21028, and 21030.
- 510(k) numbers
- ["K010938"]
- PMA numbers
- not on file
- Product code
- LLZ
- 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