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Juno DRF (2015-02-20)
- Starting date:
- February 20, 2015
- Posting date:
- March 20, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-52611
Recalled Products
A) Juno DRF
Reason
Philips has discovered that the system - in certain rare but possible combinations of user behavior (in zoom modes 30x30 and 15x15 only, but not in other zoom modes, and only in cases with manual override outside the operator's working location) - does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality.
Affected products
A) Juno DRF
Lot or serial number
13121287
484993/SN11080854
Model or catalog number
9784729831
Companies
- Manufacturer
-
Villa Sistemi Medicali S.P.A.
via Delle Azalee 3
Buccinasco
20090
ITALY