Home / Recalls / Del Mar Reynolds Medical, Ltd. / Z-1442-2014

Z-1442-2014 Class I Terminated

Recalled by Del Mar Reynolds Medical, Ltd. — Hertford, N/A

Recall Details

Product Type
Devices
Report Date
April 23, 2014
Initiation Date
March 10, 2014
Termination Date
August 20, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16 units distributed in the US

Product Description

SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.

Reason for Recall

The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.

Distribution Pattern

USA Nationwide Distribution in the states of North Carolina and South Carolina

Code Information

SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US: ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031.

Other recalls by Del Mar Reynolds Medical, Ltd.

  • Z-2093-2017 Class II — Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the (April 14, 2017)
  • Z-1460-2017 Class II — Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ve (February 8, 2017)
  • Z-1458-2015 Class II — Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs (March 5, 2015)
  • Z-0352-2014 Class I — CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, th (October 17, 2013)
  • Z-1771-2013 Class II — Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstati (June 7, 2013)
  • Z-0968-2013 Class I — Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstatio (January 15, 2013)
  • Z-0565-2013 Class II — BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia (November 2, 2012)