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Health product recall

DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D 100 TYPE 5410 OR DX-D 100 WIRELESS TYPE 5411 (2015-06-05)

Starting date:
June 5, 2015
Posting date:
August 10, 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-54522

Affected Products

A. DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D 100 TYPE 5410 OR DX-D 100 WIRELESS TYPE 5411 

Reason

When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur. Capacitive touch screens rely on the electrical properties of the human body to enable you to operate the device with very light touches of a finger. However, when liquid comes in contact with the touch screen it may incorrectly recognize this as user input.

Affected products

A. DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D 100 TYPE 5410 OR DX-D 100 WIRELESS TYPE 5411

Lot or serial number

> 10 numbers, contact mfg.

Model or catalog number
  • SM-40HF-B-D-C
  • SM-40HF-B-D-T
  • SM-40HF-B-D-V
  • SM-50HF-B-D-C
  • SM-50HF-B-D-T
  • SM-50HF-B-D-V
Companies
Manufacturer

AGFA Healthcare N.V.

Septestraat 27

Mortsel

2640

BELGIUM