Food, drugs, devices › Philips North America, LLC
Device recall: Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013
FDA enforcement event 84756 is a device recall by Philips North America, LLC of Andover, MA, initiated 30 Dec 2019 and classified Class II, with 9 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 17 Nov 2022. Initiation: voluntary: firm initiated. Philips North America, LLC has 129 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips North America, LLC, Andover, MA.
Reason for recall
"A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible."
Distribution
"Nationwide domestic distribution. Foreign distribution worldwide."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1486-2020 | Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator. | 4938 | Class II | Terminated | 25 Mar 2020 |
| Z-1487-2020 | Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044) | 70 | Class II | Terminated | 25 Mar 2020 |
| Z-1488-2020 | Integris Allura 9, system codes 722018 722021 | 20 | Class II | Terminated | 25 Mar 2020 |
| Z-1489-2020 | MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038 | 534 | Class II | Terminated | 25 Mar 2020 |
| Z-1490-2020 | OmniDiagnost Eleva System codes 708028 708027 | 69 | Class II | Terminated | 25 Mar 2020 |
| Z-1491-2020 | Poly G Integris H5000, System code 72246 | 1 | Class II | Terminated | 25 Mar 2020 |
| Z-1492-2020 | UroDiagnost Eleva, system code 708033 | 4 | Class II | Terminated | 25 Mar 2020 |
| Z-1493-2020 | Allura CV20, system code 722031 | 128 | Class II | Terminated | 25 Mar 2020 |
| Z-1494-2020 | Cardio Vascular-Allura Centron, system code 722400 | 87 | Class II | Terminated | 25 Mar 2020 |
Context
Other enforcement events for Philips North America, LLC
All 129 events for Philips North America, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide domestic distribution. Foreign distribution worldwide."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Nov 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.