The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1554-2025·Announced 2025-04-23

Philips DXR System DuraDiagnost Rel. 4 X-Ray System Collimator Fall Risk

Philips is recalling 83 units of the DXR System, DuraDiagnost Rel. 4 stationary X-ray system due to potential for the collimator to fall if incorrectly installed. The defect could pose injury risk to patients or staff.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a risk-of-harm product (falling collimator on an X-ray system that could injure patients or staff). No illnesses or injuries have been reported in the source text, but the hazard is not purely theoretical—it is a mechanical failure mode with direct injury potential. This meets the High severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips North America LLC is recalling 83 units of the Philips DXR System, DuraDiagnost Rel. 4 stationary X-ray system due to a potential for the collimator to fall as a result of incorrect installation. The affected units are identified by serial numbers SN170009, SN170010, SN180072, SN180020, 200037, SN160061, SN180075, 200089, SN180045, and SN160096.

The devices have been distributed nationwide across Alaska, Florida, Kansas, Mississippi, New Hampshire, New York, Oregon, Pennsylvania, Texas, and Wisconsin, as well as internationally to Argentina, Australia, Canada, Chile, China, Germany, Hungary, India, Indonesia, Italy, Kenya, Mexico, the Netherlands, New Zealand, Oman, Pakistan, Peru, Poland, Romania, the Russian Federation, Slovenia, South Africa, Spain, Thailand, the United Kingdom, and Vietnam.

If you own or operate one of these units, verify the installation of the collimator to ensure it is properly secured. Contact Philips North America LLC for guidance on inspection and corrective action. For more information, refer to the FDA recall notice Z-1554-2025.

The recalled product

Product
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Manufacturer
Philips North America Llc
Category
Medical Device — X-Ray System
Hazard
Affected units
83

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • REF 712214
  • UDI: (01)00884838064751(21)
  • Serial No. SN170009
  • SN170010
  • SN180072
  • SN180020 200037
  • SN160061
  • SN180075
  • 200089
  • SN180045
  • SN160096.

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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