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FDA Medical Device Recalls (openFDA)

Philips Medical Systems North America Co. Phillips: AD6 table, modified, used with the XPER systems. The modification on the table is the cables used for connecting to the XPER systems.

Recall number
Z-0209-06
Recalling firm
Philips Medical Systems North America Co. Phillips
Product
AD6 table, modified, used with the XPER systems. The modification on the table is the cables used for connecting to the XPER systems.
Status
Terminated
Initiated
2005-10-12
Posted
2005-11-29
Terminated
2011-03-09
Reason
Potential for high voltage exposure involving the injector interface connector of patient support tables.
Root cause
Other
Action
On 10/10/05 the firm issued a letter to customers alerting customers to the problem and advising that the firm will perform an upgrade to the devices at customer sites. In March 2006 the firm issued a second notification letter involving more units.
Quantity
see total above
Distribution
Devices were distributed nationwide to hospitals/medical centers.
Lot, serial or model codes
see site numbers listed above
510(k) numbers
["K033737","K041949"]
PMA numbers
not on file
Product code
IZI
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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