Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option
FDA Recall Z-0060-2008 · Posted 2007-11-10
Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeJAA
Date Initiated2007-08-23
Date Terminated2010-09-27
Product Quantity37 units
Reason for Recall
System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control.
Firm 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.
Root Cause
Software design
Distribution Pattern
Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.