Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.

FDA device recall Z-1554-2025 · posted 2025-04-11 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

Reason for recall

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

Action taken

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).

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KPR

Quantity affected

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, Ital

Date initiated

2025-03-10

Date posted

2025-04-11

Location

Cambridge, MA

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