Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062

FDA device recall Z-1595-2023 · posted 2023-05-17 · Open, Classified

Recall details

Recalling firm

Steris Corporation

Reason for recall

In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.

Action taken

An URGENT MEDICAL DEVICE FIELD CORRECTION dated 3/28/23 was sent to customers. STERIS Action: All affected Customers will be contacted by a STERIS Service Technician to arrange an onsite inspection of their unit(s) to perform the correction. User Action: Users can continue to use their Reliance Vision Multi-Chamber Washer/Disinfector prior to completion of the correction. Should your unit alarm Drying Temperature Too High, abort the cycle, turn off the power to the unit, and contact STERIS. The competent (regulatory) authority of your country has been informed of this notice. Customer response is not required. Users are reminded to report any adverse events via FDA s MedWatch Database should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please contact Senior Product Manager at 440-392-7571, STERIS Customer Service at 1-800-548-4873, or your local STERIS Representative.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

MEC

Quantity affected

322 units

Distribution

Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: China, Lithuania, Saudi Arabia, Korea, Republic of, Canada, Taiwan, United Kingdom, Spain, Australia, New Zealand, Spain, Bra

Date initiated

2023-04-10

Date posted

2023-05-17

Location

Mentor, OH