FDA · Medical device recall

DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered… and 1 more product

April 4, 2018 Class II

Date: April 4, 2018
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: GE Healthcare, LLC
Reason: Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
Distribution pattern: US Distribution to states of: AZ, IL NC, NH and PA.

2 products in this recall

DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation…

Product: DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.
Quantity: 28
Codes and lots: Model # M1107626 Mfg. Lot or Serial #: BEJN05568, BEJM03853, BEJM04539, BEJN05793, BEJP01947, BEJP03924, BEJP04380, BEJP08533, BEJU06631, BEJN06095, BEJP04706, BEJU05053, BEJM04542, BEJM04881, BEJM04901, BEJN07748, BEJN07849, BEJP03230, BEJP03239, BEJP03559, BEJP03984, BEJP05309, BEJP05347, BEJP05825, BEJP05834, BEJP05978, BEJP08567, and BEJP09304.
Recall started: Oct. 4, 2017
Device type: Vaporizer, Anesthesia, Non-Heated
Root cause (FDA): Process control
What the company told customers: The firm, GE healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 4th, 2017 to all their customers. The letter described the product, problem and actions to be taken. The customers were instructed to contact GE Service to obtain an RMA number. GE Healthcare has arranged with Piramal Inc. to replace the affected products at no cost. If you have any questions or concern regarding this notification please contact GE healthcare Service at 1-800-437-1171 or your local representative.
Recall number: Z-1198-2018

DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent

Product: DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
Quantity: 2
Codes and lots: Model 1100-9034-000 Mfg. Lot or Serial # BGBQ00675 and BGBQ01187
Recall started: Oct. 4, 2017
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Process control
What the company told customers: The firm, GE healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 4th, 2017 to all their customers. The letter described the product, problem and actions to be taken. The customers were instructed to contact GE Service to obtain an RMA number. GE Healthcare has arranged with Piramal Inc. to replace the affected products at no cost. If you have any questions or concern regarding this notification please contact GE healthcare Service at 1-800-437-1171 or your local representative.
Recall number: Z-1199-2018

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1198-2018, Z-1199-2018. The agency record governs; check it and the company before acting.

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