Food, drugs, devices › Philips North America, LLC
Device recall: Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging
FDA enforcement event 86901 is a device recall by Philips North America, LLC of Andover, MA, initiated 19 Nov 2020 and classified Class II, with 1 product record.
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. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 19 Apr 2023. 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 software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient."
Distribution
"Worldwide distribution - US Nationwide distribution and the countries of Canada, Mexico, Algeria, Argentina, Australia, Bahrain, Austria, Belgium, Brazil, China, Columbia, Cuba, Cyprus, Czech…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0852-2021 | Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. | 2714 | Class II | Terminated | 20 Jan 2021 |
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 software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient."
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 - US Nationwide distribution and the countries of Canada, Mexico, Algeria, Argentina, Australia, Bahrain, Austria, Belgium, Brazil, China, Columbia, Cuba, Cyprus, Czech…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Apr 2023. "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.