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 Recall Z-1198-2018 · Posted None
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeCAD
Date Initiated2017-10-04
Date Terminated2020-04-10
Product Quantity28
Reason for Recall
Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
US Distribution to states of: AZ, IL NC, NH and PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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