FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1318-2012
- 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.
- Status
- Terminated
- Initiated
- 2011-11-29
- Posted
- 2012-03-26
- Terminated
- 2012-07-03
- 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
- Lot, serial or model codes
- None
- 510(k) numbers
- ["K061102"]
- PMA numbers
- not on file
- Product code
- BSZ
- Firm FEI
- 3002807907
- Firm city
- Abingdon
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28