Health product recall

MultiDiagnost Eleva - Image Intensifier and Flat Detector, ALLURA XPER (FD10, FD20, FD20/10, FD20/15, FD20/20) (2019-02-24)

Starting date:
February 24, 2019
Posting date:
March 8, 2019
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-69248

Affected Products

  1. MultiDiagnost Eleva - Image Intensifier - TV Image Detector
  2. Multidiagnost Eleva - Flat Detector - Image Detector
  3. ALLURA XPER FD20/10 System - Main Unit
  4. ALLURA XPER FD10
  5. ALLURA XPER FD20 System - Main Unit
  6. ALLURA XPER FD20 (Product of AlluraClarity Family)
  7. ALLURA XPER FD20/20 (PRODUCT OF ALLURACLARITY FAMILY)
  8. ALLURA XPER FD20/15

Reason

If a footswitch is frequently used on an anti-fatigue mat, on a non-flat surface or in the pedestal, the footswitch pedals may get bent.

Affected products

A. MultiDiagnost Eleva - Image Intensifier - TV Image Detector

Lot or serial number

Not applicable.

Model or catalog number

0708MD02

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS


B. Multidiagnost Eleva - Flat Detector - Image Detector

Lot or serial number

Not applicable.

Model or catalog number

0708MD02

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS


C. ALLURA XPER FD20/10 System - Main Unit

Lot or serial number

Not applicable.

Model or catalog number

ALLURA XPER FD20/10

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS


D. ALLURA XPER FD10

Lot or serial number

Not applicable.

Model or catalog number

ALLURA XPER FD10

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS


E. ALLURA XPER FD20 System - Main Unit

Lot or serial number

Not applicable.

Model or catalog number

ALLURA XPER FD20

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS


F. ALLURA XPER FD20 (Product of AlluraClarity Family)

Lot or serial number

Not applicable.

Model or catalog number

722028

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS


G. ALLURA XPER FD20/20 (Product of AlluraClarity Family)

Lot or serial number

Not applicable.

Model or catalog number

722038

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS


H. ALLURA XPER FD20/15

Lot or serial number

Not applicable.

Model or catalog number

722058

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS