Reported Jan 20, 2021 · Terminated
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging…
Philips North America, LLC
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 North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Emission Computed Tomography System
- Image Process System - Product Usageintended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body
- Lot codes and dates
Model# 882310882311882313 All Lots
- Amount recalled
- 2714
Where it was sold
- Nationwide
Why it was recalled
A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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