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FDA Medical Device Recalls (openFDA)

Philips Medical Systems Sales & Service Region No. America: Bucky Diagnost FS Part number 9890-010-83651

Recall number
Z-0268-04
Recalling firm
Philips Medical Systems Sales & Service Region No. America
Product
Bucky Diagnost FS Part number 9890-010-83651
Status
Terminated
Initiated
2003-11-18
Posted
2003-12-24
Terminated
2005-04-11
Reason
Support chain attachment on the Bucky carriage may fail and cause the counter weights or X-ray tube to fall.
Root cause
Other
Action
The firm mailed a letter to their customers on November 18, 2003 stating upgrades will begin November 14, 2003.
Quantity
3 units
Distribution
The firm distributed to three medical facilities in Florida, New York and California.
Lot, serial or model codes
Site numbers: 504495, 105355, 104447. The firm uses site numbers instead of serial numbers.
510(k) numbers
["K945278"]
PMA numbers
not on file
Product code
KPR
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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