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Health product recall

ALLURA XPER SYSTEMS (2016-02-18)

Starting date:
February 18, 2016
Posting date:
March 4, 2016
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-57414

Affected Products

  • A. ALLURA XPER FD20/10 SYSTEM-MAIN UNIT
  • B. ALLURA XPER FD10
  • C. ALLURA XPER FD20 SYSTEM-MAIN UNIT

Reason

Philips has become aware of a failure with the image disk causing the entire image processing chain to be blocked due to a SW design error. This causes image data to be lost, and eventually loss of live imaging functionality.

Affected products

A. ALLURA XPER FD20/10 SYSTEM-MAIN UNIT

Lot or serial number

ALL

Model or catalog number

ALLURA XPER FD20/10

Companies
Manufacturer
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684
NETHERLANDS

B. ALLURA XPER FD10

Lot or serial number

ALL

Model or catalog number

ALLURA XPER FD10

Companies
Manufacturer
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684
NETHERLANDS

C. ALLURA XPER FD20 SYSTEM-MAIN UNIT

Lot or serial number

ALL

Model or catalog number

ALLURA XPER FD20

Companies
Manufacturer
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684
NETHERLANDS