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FDA Medical Device Recalls (openFDA)

Siemens Medical Solutions USA, Inc: Siregraph CF X-Ray System. Fluoroscopic image intensified. Model number 4466041

Recall number
Z-1476-04
Recalling firm
Siemens Medical Solutions USA, Inc
Product
Siregraph CF X-Ray System. Fluoroscopic image intensified. Model number 4466041
Status
Terminated
Initiated
2004-06-07
Posted
2004-09-18
Terminated
2005-08-18
Reason
X-ray tube movement when table is tilted more than 90 degrees
Root cause
Other
Action
The recalling firm issued a Customer DAfety Advisory letter dated 6/7/04 to the hospitals. The letter informs them of the potential problem and provides preventative measures to avoid its occurance.
Quantity
1 unit
Distribution
The products were shipped to medical facilities in FL, IL, MI, NH, NJ, PA, and TX.
Lot, serial or model codes
Serial number: 3131.
510(k) numbers
["K960266"]
PMA numbers
not on file
Product code
JAA
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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