Recall Z-1318-2012 ยท BSZ Gas-Machine, Anesthesia
Penlon, Ltd.
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.
| Date | Mar 26, 2012 (initiated Nov 29, 2011) |
| Status | Terminated |
| Reason | Penlon, Ltd has identified the potential for the premature failure of a component in some Electronic Flowmeter sensor display unit PCB assemblies. |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061102 | PRIMA ANAESTHESIA MACHINE Penlon , Ltd., Jul 28, 2006 |