Z-1318-2012

Anesthesia Machines (digital display assembly); A gas machine for anesthesia is a device used to administer...

Name: Z-1318-2012 Anesthesia Machines (digital display assembly); A gas machine for anesthesia is a device used to administer...
Creator: Penlon, Ltd.
Published: 2011-11-29
License: https://open.fda.gov/license/

Penlon, Ltd. / initiated 2011-11-29 / Terminated / root cause: design

FDA source

Penlon, Ltd. began a recall of Anesthesia Machines (digital display assembly); A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a... on 2011-11-29. The reason FDA records is "Penlon, Ltd has identified the potential for the premature failure of a component in some Electronic Flowmeter sensor display unit PCB assemblies". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1318-2012
Status: Terminated
Initiated: 2011-11-29
Posted: 2012-03-26
Terminated: 2012-07-03
Recalling firm: Penlon, Ltd.
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.
Product code: BSZ Gas-Machine, Anesthesia
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.
Root cause tag: design
FDA 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 [email protected].
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
Product codes and lots: None

Product code BSZ

K061102Class IIPrima Anaesthesia MachinePenlon , Ltd. / cleared 2006-07-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)