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U.S. Department of Health and Human Services

Class 2 Device Recall Penlon Prima Anaesthesia Machines (SP2 and SP3) with Electronic Flowmeter Display

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 Class 2 Recall
Penlon Prima Anaesthesia Machines (SP2 and SP3) with Electronic Flowmeter Display		 see related information
Date Posted March 26, 2012
Recall Status1 Terminated on July 03, 2012
Recall Number Z-1318-2012
Recall Event ID 60647
Premarket Notification
510(K) Number		 K061102 
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
Product 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.
Code Information None
Recalling Firm/
Manufacturer		 Penlon, Ltd.
Abingdon Science Park
Barton Lane
Abingdon
Manufacturer 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.
FDA Determined
Cause 2		 DESIGN: Component Design/Selection
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 techsupport@penlon.com.
Quantity in Commerce 160 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Peru, Uganda, Kenya, Malaysia, Poland, Saudi Arabia, United Arab Emirates, Philippines, Equador, and Thailand
Total Product Life Cycle TPLC Device Report
 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = PENLON LTD.
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