Philips Medical System - BV Pulsera Mobile C-arms with Remote Control Option, (Release 2)
FDA device recall Z-0059-2008 · posted 2007-11-10 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control.
- Action taken
- 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
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 596 units
- Distribution
- Nationwide
- Date initiated
- 2007-08-23
- Date posted
- 2007-11-10
- Date terminated
- 2010-09-27
- Location
- Bothell, WA
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