High FDA (Devices)·Z-2322-2017·Announced 2017-06-21

Philips DuraDiagnost X-ray systems recalled for cracked welding joints

Philips is recalling 98 DuraDiagnost X-ray systems because the tube arm assembly could fall due to cracked welding joints.

What this means for you

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: The recall involves a risk-of-harm product (falling heavy equipment) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Philips Electronics North America Corporation is recalling 98 units of the Philips DuraDiagnost X-ray systems, including R1.0, R2.0, and R3.0 models. The recall is due to a defect where the tube arm assembly could fall down because of cracked welding joints.

The affected units were distributed worldwide, including in the United States (California and Ohio) and numerous international locations. Specific serial numbers are listed in the official recall documentation.

Healthcare facilities should contact Philips to arrange for inspection and repair of the affected equipment to prevent potential injury from the falling assembly.

The recalled product

Product: Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211)
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — X-ray Systems
Hazard: falling-object
structural-defect
Affected units: 98

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 (14)

SN120001-SN120003
SN130001-SN130023
SN140001-SN140022
SN140024
SN140027
SN140030-SN140031
SN140033-SN140046
SN140048
SN140050-SN140068
SN150001-SN150004
SN150006
SN150008-SN150011
SN160001
SN160002

Distribution

Distributed in 2 states:

Same manufacturer · Philips Electronics North America Corporation

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Same hazard · falling object