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FDA Medical Device Recalls (openFDA)

Siemens Medical Solutions USA, Inc: Sienet Cosmos. Radiological Image Processing. Model number 10018971

Recall number
Z-0092-06
Recalling firm
Siemens Medical Solutions USA, Inc
Product
Sienet Cosmos. Radiological Image Processing. Model number 10018971
Status
Terminated
Initiated
2005-09-22
Posted
2005-10-28
Terminated
2006-08-23
Reason
reference lines appear above actual position
Root cause
Other
Action
The company has issued a Customer Safety Advisory dated 9/22/05 via certified mail to the affected customers per Update Instructions CN038/05/S. The letter informs customers of the issue and also provides customer with instruction to avoid its occurrence.
Quantity
64 units
Distribution
The product was shipped to medical facilities in CA, CO, FL, IA, KS, LA, MD, MI, MO, NC, and PA.
Lot, serial or model codes
model number 10018971  version VB15C
510(k) numbers
["K042832"]
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

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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

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