—#162478

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.

FDA product code: CAD — Vaporizer, Anesthesia, Non-Heated
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K012924
Affected lot / code info: 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.

Why it was recalled

Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: US Distribution to states of: AZ, IL NC, NH and PA.

Timeline

Recall initiated: 2017-10-04
Terminated: 2020-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162478. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.