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Terminated

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

FDA Recall Z-1199-2018 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeBSZ
Date Initiated2017-10-04
Date Terminated2020-04-10
Product Quantity2

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.

K170872Aisys CS2Datex-Ohmeda, Inc. · 2017-08-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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