FDA Recall 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.

Recall: Z-1318-2012 · Initiated November 29, 2011

Recall

Recall Number
Z-1318-2012
Event Number
60647
Firm
Penlon, Ltd. Abingdon Science Park Barton Lane Abingdon United Kingdom
FEI Number
3002807907
Product Code
BSZ
Status
Terminated
Root Cause
Component design/selection
Initiated
November 29, 2011
Posted
March 26, 2012
Terminated
July 3, 2012

Description

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.

Reason

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

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].

Distribution

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

Quantity

160 units