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.
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: 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
- 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
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