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FDA Medical Device Recalls (openFDA)

Philips Medical Systems North America Co. Phillips: MD3 X-ray system

Recall number
Z-0851-06
Recalling firm
Philips Medical Systems North America Co. Phillips
Product
MD3 X-ray system
Status
Terminated
Initiated
2006-04-06
Posted
2006-05-06
Terminated
2008-05-21
Reason
Potential for unexpected table movement.
Root cause
Other
Action
On 4/6/06 the firm issued a letter to consignees advising of the problem. The letter advises consignees to conduct a test on their unit(s) for a possible short until the firm is able to upgrade the units.
Quantity
37units
Distribution
Units were distributed to hospitals and medical centers located throughou the US.
Lot, serial or model codes
Site numbers 59515, 38929, 76329, 83654, 82673, 35471, 59524, 86146, 38922, 101151, 38714, 38716, 44865, 6847, 103855, 26071, 103856, 40941, 83047, 62502, 38266, 38422, X1198, 50317, 38289, 17669, 6931, X0917, 26019, 26020, 13661, 38418, 59571, 41462, 82721, 101782, 103209
510(k) numbers
["K904012"]
PMA numbers
not on file
Product code
JAA
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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