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Del Mar Reynolds Medical Recalls
8 recalls on record · December 26, 2012 to May 24, 2017 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 24, 2017Medical DevicesFDA
Del Mar Reynolds Medical, Ltd. recalls Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room
Hazard: Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient.
March 22, 2017Medical DevicesFDA
Del Mar Reynolds Medical, Ltd. recalls Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery S
Hazard: Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting down without warning. The power supply has failed in a way that does not trigger the normal on battery alarms.
April 29, 2015Medical DevicesFDA
Del Mar Reynolds Medical, Ltd. recalls Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventila
Hazard: Reports of inaccurate low flow readings. Monitored inspiratory tidal volume (VTi) and expiratory tidal volume (Vte) measurements from the pediatric flow sensor are reporting out of specification low compared to the actual delivered volumes being administered to the patient.
April 23, 2014Medical DevicesFDA
Del Mar Reynolds Medical, Ltd. recalls SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Hazard: The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
November 27, 2013Medical DevicesFDA
Del Mar Reynolds Medical, Ltd. recalls CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation wit
Hazard: Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber.
July 31, 2013Medical DevicesFDA
Del Mar Reynolds Medical, Ltd. recalls Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxyge
Hazard: 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.
March 27, 2013Medical DevicesFDA
Del Mar Reynolds Medical, Ltd. recalls Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Se
Hazard: A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient.
December 26, 2012Medical DevicesFDA
Del Mar Reynolds Medical, Ltd. recalls BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the cust
Hazard: The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not been incorporated into the system. The manuals were prematurely updated for a feature that is not yet available.