FDAClass IIApril 23, 2025

Philips DXR System recall

Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.

Why was Philips DXR System recalled?

Potential for collimator to fall as a result of incorrect installation.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

REF 712203; UDI: (01)00884838095205(21); Serial No. 220025, 210023, 220171, 230103, 230152.

Product
Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
Recalling firm
Philips North America Llc
Quantity
83 units
Distribution
Worldwide - US Nationwide distribution in the states of AK, FL, KS, MS, NH, NY, OR, PA, TX, WI and the countries of Argentina, Australia, Canada, Chile, China, Germany, Hungary, India, Indonesia, Italy, Kenya, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Poland, Romania, Russian Federation, Slovenia, South Africa, Spain, Thailand, United Kingdom, Vietnam.
Recall date
April 23, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls