Recall Z-0815-2025— GE Medical Systems, LLC

Name: FDA recall Z-0815-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-18

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2024-11-18. It names one FDA 510(k) clearance: K172702. Product: Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO. Reason: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Ongoing
Initiated: 2024-11-18
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K172702 — Tec 820, Tec 850Datex-Ohmeda, Inc.·cleared 2018-01-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO

Reason for recall

Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.

Data sourced from openFDA. This site is unofficial and independent of the FDA.