CLASS II Device recall · Reported 30 Jun 2021 · FDA Enforcement Report
Philips Allura Xper System: Interventional Fluoroscopic recalled
Philips Medical Systems Nederlands is recalling Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, distributed in 10 states. The recall was initiated on 23 Jun 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1904-2021
- FDA event ID
- 87978
- Recalling firm
- Philips Medical Systems Nederlands, Best, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jun 2016
- FDA classified
- 21 Jun 2021
- Reported
- 30 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 23 Jun 2016 | Recall initiated by company | |
| 21 Jun 2021 | Classified by FDA | +1824 days |
| 30 Jun 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
Where it was distributed
Worldwide distribution. US states of: AL, AZ, FL, GA, IL, MA, MO, NJ, OR, and VA; Netherlands, United Kingdom, Poland, Spain, France, Czech Republic, India, Brazil, Singapore, Japan, Colombia, United Arab Emirates, China, Russian Federation, Oman, and Mexico.
AlabamaArizonaFloridaGeorgiaIllinoisMassachusettsMissouriNew JerseyOregonVirginia
Questions about this recall
Is Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026 recalled?
Yes. Philips Medical Systems Nederlands recalled Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026 on 23 Jun 2016. The recall is Class II and its status is Terminated. Recall number Z-1904-2021.
Why was it 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.
Which lots are affected?
Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058. Date(s) of Distribution: 16-SEP-2014 - 04-MAY-2016. System equipment numbers: 64937259 65862117 63304032 63151474 63250793 63303889 63304149 64140063 63855729 63516113 64077887 66407452 66350303 65342973 63210187 63511276; 66923399 66422060 64085323 61099178 64103799 67936786 66730784 66736708 66628236 63883590 64916638 64927462 65345691 66517161 66403768 63218881 67360962 69856976 65258983 66167983 64778594 61655917 65206981 67874859
Where was it sold?
Worldwide distribution. US states of: AL, AZ, FL, GA, IL, MA, MO, NJ, OR, and VA; Netherlands, United Kingdom, Poland, Spain, France, Czech Republic, India, Brazil, Singapore, Japan, Colombia, United Arab Emirates, China, Russian Federation, Oman, and Mexico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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