Health product recall

MultiDiagnost Eleva- Flat Detector-Image Detector System - 2019-12-27

Starting date:
December 27, 2019
Posting date:
January 20, 2020
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-72127

Last updated: 2020-01-21

Affected Products

  1. MultiDiagnost Eleva- Flat Detector-Image Detector
  2. OmniDiagnost Eleva
  3. Allura Xper FD10
  4. Allura Xper FD10(Product of Alluraclarity Family)
  5. Allura Xper FD20(Product of Alluraclarity Family)
  6. Allura Xper FD10/10(Product of Alluraclarity Family)

Reason

Philips identified that a capacitor inside the convertor of the velara x-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible anymore. The failed capacitor may produce smoke and a burning odor in the room where the generator is located. If the system is a biplane model, x-ray acquisition is still possible on the other channel. If the system is a monoplane, it cannot be used anymore until the capacitor is replaced.

Affected products

A. 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

B. OmniDiagnost Eleva

Lot or serial number

Not applicable.

Model or catalog number

708028

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS

C. Allura Xper FD10

Lot or serial number

Not applicable. 

Model or catalog number

1443

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS

D. Allura Xper FD10(Product of Alluraclarity Family)

Lot or serial number

Not applicable.

Model or catalog number

722026

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS

E. 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

F. Allura Xper FD10/10(Product of Alluraclarity Family)

Lot or serial number

Not applicable.

Model or catalog number

722027

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS