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Health product recall

WELCH ALLYN SURESIGHT VISION SCREENER(2015-08-12)

Starting date:
August 12, 2015
Posting date:
October 8, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-55270

Affected Products

WELCH ALLYN SURESIGHT VISION SCREENER

Reason

During service, SureSight Vision Screeners were calibrated and the calibration activity performed may not have returned the device to working order. In its current state, the device will most likely not be able to take a reading or it may be very difficult to get a reading. Devices affected are limited to those serviced between July 17, 2015 and August 7, 2015 at the Welch Allyn Skaneateles Falls location.

Affected products

WELCH ALLYN SURESIGHT VISION SCREENER

Lot or serial number
  • 200700393
  • 200700403
  • 200700405
  • 200700407
  • 200700495
  • 200800014
Model or catalog number
  • 14016
Companies
Manufacturer

Welch Allyn Inc.

4341 State Street Road

Skaneateles Falls

13153-0220

New York

UNITED STATES