Anesthesia Machines (digital display assembly); A gas machine for anesthesia is a device used to administer to a patient
FDA device recall Z-1318-2012 · posted 2012-03-26 · Terminated
Recall details
- Recalling firm
- Penlon, Ltd.
- 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.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 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
- Date initiated
- 2011-11-29
- Date posted
- 2012-03-26
- Date terminated
- 2012-07-03
- Location
- Abingdon, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRIMA ANAESTHESIA MACHINE (K061102) | Penlon , Ltd. | 2006-07-28 |