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ALLURA XPER FD (2015-06-22)
- Starting date:
- June 22, 2015
- Posting date:
- July 17, 2015
- 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-54236
Affected Products
- Allura XPER FD10/10
- Allura XPER FD20/10
- Allura XPER FD20/20
- Allura XPER FD10
- Allura XPER FD20
Reason
Philips had received a call with respect to an issue with a failing Monitor Ceiling Suspension (MCS) actuator of an Allura Xper system. The actuator assembly had become detached and the monitor carriage with a FlexVision monitor dropped to its lowest position. The monitor ceiling suspension is designed to allow flexible positioning near the patient table when in use, and away from the patient when not in use. (Park position).
Affected products
A. Allura XPER FD10/10
Lot or serial number
>10, contact mfg.
Model or catalog number
ALLURA XPER FD10/10
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands
B. Allura XPER FD20/10
Lot or serial number
>10, contact mfg.
Model or catalog number
Allura XPER FD20/10
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands
C. Allura XPER FD20/20
Lot or serial number
>10, contact mfg.
Model or catalog number
Allura XPER FD20/20
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands
D. Allura XPER FD10
Lot or serial number
>10, contact mfg.
Model or catalog number
Allura XPER FD10
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands
E. Allura XPER FD20
Lot or serial number
>10, contact mfg.
Model or catalog number
Allura XPER FD20
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands