Z-1553-2025Class II

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

Name: Z-1553-2025 Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System
Creator: Philips North America Llc
Published: 2025-03-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2025-03-10 / Open, Classified

FDA source

Philips North America Llc began a recall of Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System on 2025-03-10. FDA classified it as Class II and gives the reason as "Potential for collimator to fall as a result of incorrect installation". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1553-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-10
Posted: 2025-04-11
Recalling firm: Philips North America LLC
Product: Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
Product code: KPR System, X-Ray, Stationary
Reason for recall: Potential for collimator to fall as a result of incorrect installation.
FDA root cause: Under Investigation by firm
Action: 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).
Quantity in commerce: 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.
Product codes and lots: REF 712203; UDI: (01)00884838095205(21); Serial No. 220025, 210023, 220171, 230103, 230152.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1553-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1553-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-11
Z-1554-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-11

Product code KPR

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)