Getinge Usa Sales Inc recalls Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR…
Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of ventilation. If the device stops ventilating due to this issue, it may lead to…
Read the official notice →- Date
- 2022-08-31
- Country
- United States
- Brand
- Getinge Usa Sales
- Product
- Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR…
- Classification
- Class I
- Units
- Worldwide distribution. US nationwide, Poland, Spain, France, Germany, Czech…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Getinge Usa Sales recalls
- 2022-12-14
USGetinge Usa Sales Inc recalls Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to provide the expected run time in the event of a mains power…
FDA · DeviceGetinge Usa Sales IncUS Nationwide distribution in the states of CO, FL, IN, MA, MO, and VA.Official notice →- 2022-11-23
- US
Getinge Usa Sales Inc recalls Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
The back rest may unintentionally drop suddenly, resulting in adverse health consequences if a patient were to fall on the floor head first and at a steep angle.
FDA · DeviceGetinge Usa Sales IncWorldwide - US Nationwide distribution in the states of MA, NJ, SC, and TN.…Official notice → - 2022-08-31
- US
Getinge Usa Sales Inc recalls Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric…
Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be…
FDA · DeviceGetinge Usa Sales IncWorldwide distribution - US Nationwide and the countries of Australia (AU),…Official notice → - 2022-07-06
- US
Getinge Usa Sales Inc recalls VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961…
Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical…
FDA · DeviceGetinge Usa Sales IncWorldwide distribution - US Nationwide distribution in the states of AR, AZ,…Official notice → - 2022-06-29
- US
Getinge Usa Sales Inc recalls Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product…
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being…
FDA · DeviceGetinge Usa Sales IncUS Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri,…Official notice → - 2022-06-15
- US
Getinge Usa Sales Inc recalls Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying…
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a…
FDA · DeviceGetinge Usa Sales IncUS Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.Official notice →
Other drugs & medical recalls in the United States
- 2022-08-31
- US
bioMerieux, Inc. recalls NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
FDA · DevicebioMerieux, Inc.Distribution was made to AR, AZ, CA, CT, FL, IL, IN, KS, KY, MA, MD, MI, MN,…Official notice → - US
DeRoyal Industries Inc recalls DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick…
The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.
FDA · DeviceDeRoyal Industries IncUS Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV.Official notice → - US
Synapse Biomedical Inc recalls NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrade over time. Depending on the failure mode, potential adverse events include pain, muscle fatigue and…
FDA · DeviceSynapse Biomedical Incdistribution to US states of AL, CO, IL, FL, GA, MD, MN, NC, NJ, OH, PA, and…Official notice → - US
Aizu Olympus Co., Ltd. recalls EVIS EXERA III Bronchovideoscope
The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner.
FDA · DeviceAizu Olympus Co., Ltd.US Nationwide distribution in the states of FL, IL, NC, PA & TX.Official notice → - US
Hamilton Medical AG recalls HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Ventilator status indicator board can become loose, which could lead to water ingress (disinfectants) that may lead to technical fault alarms. Multiple technical faults in a short time may force ventilators into Safety…
- US
Intera Oncology, Inc. recalls INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Higher than expected flow rate.
FDA · DeviceIntera Oncology, Inc.US distribution to states of: AL, CA, IL, KY, MN, MO, NC, NJ, NY, OH, OR, PA,…Official notice →