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FDA Medical Device Recalls (openFDA)

Philips Medical Systems: Easy Access PACS System with software Release 5, 6.2, or 7.2

Recall number
Z-1223-03
Recalling firm
Philips Medical Systems
Product
Easy Access PACS System with software Release 5, 6.2, or 7.2
Status
Terminated
Initiated
2002-02-13
Posted
2003-09-12
Terminated
2005-04-11
Reason
Potential display of an incorrect body part description on patient images.
Root cause
Other
Action
On 2/13/02 the firm issued a letter to their consignees. The letter provided a remedy to the situtaion.
Quantity
46 units
Distribution
The firm distributed units to 46 hospitals and medical centers located throughout the U.S.
Lot, serial or model codes
To be provided
510(k) numbers
["K983447"]
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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