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Class 2 Device Recall Penlon Prima Anaesthesia Machines (SP2 and SP3) with Electronic Flowmeter Display |
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Date Initiated by Firm |
November 29, 2011 |
Date Posted |
March 26, 2012 |
Recall Status1 |
Terminated 3 on July 03, 2012 |
Recall Number |
Z-1318-2012 |
Recall Event ID |
60647 |
510(K)Number |
K061102
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Product Classification |
Gas-machine, anesthesia - Product Code BSZ
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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 United Kingdom
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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.
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = BSZ and Original Applicant = PENLON LTD.
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