Del Mar Reynolds Medical, Ltd.: Medical Device Recall in 2013 - (Recall #: Z-1771-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.

Product Classification:

Class II

Date Initiated: June 7, 2013

Date Posted: July 31, 2013

Recall Number: Z-1771-2013

Event ID: 65630

Reason for Recall:

Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a yellow triangle will be displayed on the System Status Computer screen that alerts the user of this error.

Status: Terminated

Product Quantity: 9 units (4 in the US and 5 outside US)

Code Information:

ARKN-000001, ARKN-000005, ARKN-000010, ARKN-000015, ARKN-000016, ARKN-000017, ARKN-000018, ARKN-000020, ARKN-000021.

Distribution Pattern:

Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian.

Voluntary or Mandated:

Voluntary: Firm initiated