Z-0060-2008

Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option

Name: Z-0060-2008 Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option
Creator: Philips Medical Systems North America Co. Phillips
Published: 2007-08-23
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2007-08-23 / Terminated / root cause: software

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option on 2007-08-23. The reason FDA records is "System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0060-2008
Status: Terminated
Initiated: 2007-08-23
Posted: 2007-11-10
Terminated: 2010-09-27
Recalling firm: Philips North America LLC
Product: Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control.
Root cause tag: software
FDA 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 in commerce: 37 units
Distribution: Nationwide
Product codes and lots: 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

Product code JAA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)