Food, drugs, devices › Philips Medical Systems, Inc.
Device recall: Philips Medical System Allura Xper X-Ray Angiographic
Philips Medical Systems, Inc. (Andover, MA) initiated this device recall on 6 Jun 2014; FDA lists 1 product record under event 70011, classified Class II.
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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 15 Oct 2021. Initiation: voluntary: firm initiated. Philips Medical Systems, Inc. has 47 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 Medical Systems, Inc., Andover, MA.
Reason for recall
"In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound."
Distribution
"Worldwide Distribution - USA nationwide including Puerto Rico, Austria, Azerbaijan, Australia, Algeria, Argentina, Albania, Brazil, Belgium, Bangladesh, Bahamas, Bulgaria, Cambodia, Chile, Canada,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1120-2015 | Philips Medical System Allura Xper X-Ray Angiographic | 7439 | Class II | Terminated | 11 Mar 2015 |
Context
Other enforcement events for Philips Medical Systems, Inc.
All 47 events for Philips Medical Systems, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound."
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: "Worldwide Distribution - USA nationwide including Puerto Rico, Austria, Azerbaijan, Australia, Algeria, Argentina, Albania, Brazil, Belgium, Bangladesh, Bahamas, Bulgaria, Cambodia, Chile, Canada,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Oct 2021. "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.