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FDA Medical Device Recalls (openFDA)

Philips Medical Systems: Easy Access Software releases 1.1, 5.2, 6.2 & 7.2

Recall number
Z-1125-03
Recalling firm
Philips Medical Systems
Product
Easy Access Software releases 1.1, 5.2, 6.2 & 7.2
Status
Terminated
Initiated
2003-06-27
Posted
2003-08-12
Terminated
2005-01-12
Reason
If DICOM fields for body part, description or accession number are changed, change won't update on the EasyWeb client or hospital systems.
Root cause
Other
Action
On 6/25/03 the firm issued a letter dated 6/15/03 to the affected customers. The letter advises of the problem and advises the customer that the firm will install corrected software in affected units.
Quantity
46 devices
Distribution
Devices were distributed to 23 hospitals and medical centers throughout the US.
Lot, serial or model codes
The firm utilizes a site # to identify the devices: 83966, 82846, 82847,82843, 82845, 82850, 82849, 82844, 102836, 76904, 103125, 103124, 102835, 100640, 101185, 76938, 85078, 76937, 85083, 85077, 76904, 86255, 87121, 87120, 87119, 84399, 10276, 85052, 86190, 86050, X1758, X1676, 84031, 83966, 86002, 86001, X1776, 84476, 84088, 83676, 85451, 84361, 76945, 87130, 86198, 10379
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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