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Terminated

Anesthesia Machines (digital display assembly); A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.

FDA Recall Z-1318-2012 · Posted 2012-03-26

Recalling FirmPenlon, Ltd.
Recall StatusTerminated
Product CodeBSZ
Date Initiated2011-11-29
Date Terminated2012-07-03
Product Quantity160 units

Reason for Recall

Penlon, Ltd has identified the potential for the premature failure of a component in some Electronic Flowmeter sensor display unit PCB assemblies.

Firm Action

Penlon Limited sent a Technical Bulletin dated November 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. As a precaution a field upgrade part was released that required all existing PCB assemblies to be removed and the updated item installed. The old PCB must be returned to Penlon with the serial number of the affected machine. The required replacement parts were included with the technical bulletin. For further information customers should contact the Technical Support Team at [email protected].

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of Peru, Uganda, Kenya, Malaysia, Poland, Saudi Arabia, United Arab Emirates, Philippines, Equador, and Thailand

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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