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FDA Medical Device Recalls (openFDA)

Philips Medical Systems Sales & Service Region No. America: Xcelera System, image processing, radiological.

Recall number
Z-0973-04
Recalling firm
Philips Medical Systems Sales & Service Region No. America
Product
Xcelera System, image processing, radiological.
Status
Terminated
Initiated
2004-04-15
Posted
2004-07-20
Terminated
2005-04-11
Reason
Potential for the image data to be erased from the long term archive.
Root cause
Other
Action
On 4/15/04 the firm sent letters to customers advising of the problem and that a service representative will visit and conduct a software upgrade.
Quantity
56 units
Distribution
Devices were distributed to hospitals and medical centers throughout the US.
Lot, serial or model codes
Part numbers: 9896 050 73251XC1.1L1 Software binder; 9896 050 73252XC1.1L1 Sofware binder + SP2
510(k) numbers
["K022788"]
PMA numbers
not on file
Product code
LLZ
Firm FEI
1000524572
Firm city
Bothell
Firm state
WA
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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