Health product recall

The iDESIGN Refractive Studio

Last updated

Summary

Product
The iDESIGN Refractive Studio
Issue
Medical devices » Software defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or serial number

Model or catalog number

IDESIGN ADVANCED WAVESCAN STUDIO

All lots.

IDESIGN/G300

CATALYS PRECISION LASER SYSTEM

All lots.

0160-6010

IDESIGN REFRACTIVE STUDIO SYSTEM

All lots.

0110-2279

Issue

Jjsv inc. Is issuing this recall notice due to a cybersecurity vulnerability for Idesign Systems Catalys Precision laser systems utilizing microsoft windows operating systems and the print spooler functionality. The vulnerability is a remote code execution vulnerability that exists when the windows print spooler service improperly performs privileged file operations. An attacker who exploits this vulnerability could potentially run arbitrary code with system privileges. This would give them access to potentially install programs; view, change, or delete data; or create new accounts with full user rights.

Recall start date: 2021-11-09

Additional information

Details
Original published date: 2021-11-26
Alert / recall type
Health product recall
Category
Health product » Medical device » Ophthalmology
Companies

AMO MANUFACTURING USA, LLC

510 COTTONWOOD DRIVE, MILPITAS

CALIFORNIA, UNITED STATES

95035

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63654