According to a latest news FDA has issued a Class I Recall for Spacelabs Medical’s Anesthesia Workstations and Service Kits that provide oxygen, air and nitrous oxide through patient breathing circuits. The recall was initiated by the company in association with the FDA over concerns that they may contain a defect which could result in excess carbon dioxide in the gas delivered to a patient.

According to reports from the sources, the agency slapped the recall with Class I status, generally reserved for the highest-risk device defects, over concerns that excess carbon dioxide inhalation “may cause serious health consequences, including death.”

The manufacturer of the device has asked distributors, healthcare facilities and patients to cease using all BleaseFocus and BleaseSirius systems that were shipped after October 31, 2012, as well as all service kits numbered 12200902, 050-0659-00 or 050-0901-00 and any workstations containing such kits. The company has also urged everyone to report any side effects or adverse effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Customers may call Spacelabs Medical at 1-800-522-7025 and select 2 for Technical support.

Anesthesia Systems are used in healthcare facilities and hospital settings to provide respiratory support to patients, delivering a controlled flow of oxygen, air, and nitrous oxide via patient-breathing circuits.

About Spacelabs

From high to low acuity, simple to complex cases, pediatric to geriatric patients, Spacelabs Anesthesia Systems is a renowned name in the medical device manufacturing sector in the United States. The company offers a lot of product lines used for ventilation and monitoring.

What is Anesthesia?

Anesthesia is the use of drugs or chemicals to prevent the feeling of pain or any sensation during surgery or other procedures that might be painful. Usually anesthesia is given as inhaled vapors, gases or through injection. Anesthesia comes in different forms and affects the nervous system of the patient by blocking nerve impulses and therefore pain.

Precautions to be observed before Anesthesia

General anesthesia is safe for healthy people however there are some conditions where precautions need to be observed before going under Anesthesia.

  • People suffering from lung, heart or kidney problem should inform their physician about the condition
  • If you are allergic to chemicals or medical products let your doctor know about it
  • If you are a regular alcoholic inform your doctor about it as in the case you may need higher doses
  • Let your doctor know if you are using sleeping pills and tranquilizers