Recalls / —

—#212867

Product

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

FDA product code

KPR — System, X-Ray, Stationary

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K141381, K201640

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Consignees received an URGENT MEDICAL DEVICE CORRECTION NOTICE dated 3/7/25. The notice instructs customers of safety precautions to take during scan preparation to ensure devices are fit for use. If consignees notice that the laser from the collimator or crosshairs of the collimator's light field is not able to align with the silkscreen on the front cover of the detector, consignees are to immediately stop use and call their Philips representative. The provided notice is to be posted near affected systems and circulated to all device users. Philips will reach out to consignees to schedule an inspection of devices by field service engineers. Engineers may also replace the collimator, if necessary. Consignees with questions are to call Philips Customer Care Solutions Center at 1-800-722-9377 from Monday through Friday (8:00 AM to 8:00 PM EST).

Recalling firm

Firm

Philips North America Llc

Address

222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2025-03-10

Posted by FDA

2025-04-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #212867. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.