Philips DigitalDiagnost Systems Recalled for Electrical Safety Standard Non-Compliance
Philips Healthcare Inc. is recalling four DigitalDiagnost Systems because the GEO Transformer does not meet international electrical safety standards.
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 medical device with a defect in electrical safety standards (creepage distance) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips Healthcare Inc. is recalling four units of the Philips DigitalDiagnost Systems with M Cabinet, Model 712025. These are stationary radiographic systems used for digital universal RAD applications. The recall is due to a safety defect in the GEO Transformer component.
The specific issue is that the creepage distance between the two primary phases in the GEO Transformer is 4.5 mm, which does not meet the IEC International standard of 5.5 mm. This non-compliance with electrical safety standards presents a potential hazard.
The affected systems were distributed worldwide, including in the United States (specifically Ohio and Washington) and Canada. The affected units are identified by specific serial numbers associated with the M-cabinet CXA: 11-K0003, 12-B0001, 12-B0002, and 12-B0003. Users should contact Philips Healthcare Inc. for instructions on how to address this defect.
The recalled product
- Product
- Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
- Manufacturer
- Philips Healthcare Inc.
- Affected units
- 4
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 (6)
- Lot or Serial Numbers With affected M-cabinet CXA
- Serial number
- 11-K0003
- 12-B0001
- 12-B0002
- 12-B0003
Distribution
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