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DigitalDiagnost
- Starting date:
- August 8, 2012
- Posting date:
- September 3, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15565
Recalled Products
A. DigitalDiagnost
Reason
Philips has discovered an issue in the M-Cabinet of the Digitaldiagnost. The creepage distance between the two primary phases in the Geo Transformer is 4.5mm. According to IEC 60601-1 (2nd edition, clause 57.10), the international standard governing electrical specifications for electronic products, the creepage distance for a 500V AC (As found in the M-Cabinet) has to be 5.5mm.
Affected products
A. DigitalDiagnost
Lot or serial number
496371 / Serial Number: 12000057
Model or catalog number
9890-010-8390X
Companies
- Manufacturer
- Philips Medical Systems DMC GMBH