DuraDiagnost recallZ-1554-2025 · Philips North America Llc · initiated Mar 10, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for collimator to fall as a result of incorrect installation.
FDA root cause category: Under Investigation by firm
What the company is doing
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).
Recall details
- Recall number
- Z-1554-2025
- Status
- Open, Classified
- Initiated by the company
- Mar 10, 2025
- Posted by the FDA
- Apr 11, 2025
- Recalling firm
- Philips North America Llc
- Quantity
- 83 units
- Product code
- KPR
- FDA submissions
- K141381, K201640
- 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.
Product description
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Code information (models, lots, serial numbers)
REF 712214; UDI: (01)00884838064751(21); Serial No. SN170009, SN170010, SN180072, SN180020 200037, SN160061, SN180075, 200089, SN180045, SN160096.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DuraDiagnostPhilips Healthcare (Suzhou) Co., Ltd. · Solid state x-ray imager (flat panel/digital imager)1 recall1 report
Product lines
Other devices under the same FDA submission
1 device cleared under K141381, K201640 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- DuraDiagnostPhilips Healthcare (Suzhou) Co., Ltd. · System, x-ray, stationary1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96435).
- Z-1553-2025 · Open, ClassifiedPhilips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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