Reported Jun 30, 2021 · Terminated
Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029,…
Philips Medical Systems Nederlands
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems Nederlands · Veenpluis 4-6 · Best, N/A · N/A
Is this the product you have?
- Philips Allura Xper SystemInterventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058
- Lot codes and dates
Product No.: 722026722027722028722029722035722038and 722058
- Date(s) of Distribution16-SEP-2014 - 04-MAY-2016
- System equipment numbers63511276;
649372596586211763304032631514746325079363303889633041496414006363855729635161136407788766407452663503036534297363210187
669233996642206064085323610991786410379967936786667307846673670866628236638835906491663864927462653456916651716166403768632188816736096269856976652589836616798364778594616559176520698167874859
- Amount recalled
- 42 devices
Where it was sold
Why it was recalled
Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering.
This product could cause temporary or reversible health problems — stop using it.
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