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Terminated

Datex-Ohmeda S/5 Anesthesia Delivery Units

FDA Recall Z-0937-03 · Posted 2003-08-28

Recalling FirmDatex-Ohmeda Inc
Recall StatusTerminated
Product CodeBSZ
Date Initiated2003-07-15
Date Terminated2005-11-08
Product Quantity544 units

Reason for Recall

Possible disruption of mechanical ventilation or disruption of anesthetic agent delivery.

Firm Action

Recall letters dated July 15, 2003 stated that a firm representative would contact the consignees to schedule a visit to replace CPU boards to correct the problem.

Root Cause

Other

Distribution Pattern

The product was distributed nationwide to hospitals in the Unites States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K973985AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)Datex-Engstrom, Inc. · 1998-10-30

Official Source

View FDA Recall →

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

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