Del Mar Reynolds Medical, Ltd.: Medical Device Recall in 2014 - (Recall #: Z-1442-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: March 10, 2014

Date Posted: April 23, 2014

Recall Number: Z-1442-2014

Event ID: 67781

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.

Status: Terminated

Product Quantity: 16 units distributed in the US

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated