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PowerLED 700 and H. LED 700 (2014-03-14)
- Starting date:
- March 14, 2014
- Posting date:
- May 6, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-39339
Recalled products
- PowerLED 700
- H. LED 700
Reason
On PowerLED 700, the ambient light module is a set of three leds that are intended for an easy viewing of and around operating fields. In some product models, this module is attached to the cupola through a set of 4 fixing tabs, which compose the plastic enclosure of the ambient light module. There is a potential risk of failure concerning the fixation of the module. One or several fixing tabs may be broken, which may lead the ambient light module to detach, remaining attached by its wires only. The occurrence rate observed is lower than 1% and is mainly seen in the early use of the devices.
Affected products
A. PowerLED 700
Lot or serial number
Not applicable
Model or catalog number
- 700
Companies
- Manufacturer
-
Maquet S.A.
Avenue de la Pomme De Pin, Parc De Limere
Ardon, Orleans
45074
FRANCE
B. H. LED 700
Lot or serial number
Not applicable
Model or catalog number
- 700
Companies
- Manufacturer
-
Maquet S.A.
Avenue de la Pomme De Pin, Parc De Limere
Ardon, Orleans
45074
FRANCE