Philips Medical Systems North America Co. Phillips Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option
Brand
Philips Medical Systems North America Co. Phillips
Lot Codes / Batch Numbers
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
Products Sold
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
Philips Medical Systems North America Co. Phillips is recalling Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option due to System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026