FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option
- Recall number
- Z-0060-2008
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option
- Status
- Terminated
- Initiated
- 2007-08-23
- Posted
- 2007-11-10
- Terminated
- 2010-09-27
- Reason
- System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control.
- Root cause
- Software design
- Action
- On 8/23/07, the firm sent out a Safety Notification letter, via certified mail. On 8/29/07, the firm sent out an URGENT - DEVICE CORRECTION letter via regular mail, dated 8/20/07. Both letters advised customers that if the device shuts down during use, it can be restarted within about 1 minute by switching the system off and then on again, using the system on/off buttons. The letter(s) states that software is being developed to correct the problem.
- Quantity
- 37 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Serial numbers: 90, 105, 118, 119, 135, 171, 175, 176, 222, 218, 227, 226, 232, 233, 241, 248, 249, 256, 261, 262, 276, 277, 282, 303, 302, 316, 313, 304, 311, 312, 320, 327, 334, 333, 343, 345, 396
- 510(k) numbers
- not on file
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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