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…
Read the official notice →- Date
- 2022-08-31
- Country
- United States
- Brand
- Hamilton Medical
- Product
- HAMILTON-C6 Intensive Care Ventilator, REF: 160021
- Classification
- Class I
- Units
- US nationwide distribution including Puerto Rico.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Hamilton Medical recalls
- 2024-06-26
USHamilton Medical AG recalls Ventilator HAMILTON-C6, PN: 160021
Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube…
FDA · DeviceHamilton Medical AGUS Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR,…Official notice →- 2023-09-27
- US
Hamilton Medical, Inc. recalls Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption…
FDA · DeviceHamilton Medical, Inc.Distribution US nationwide, including Puerto Rico. OUS: Not providedOfficial notice → - 2023-08-02
- US
Hamilton Medical, Inc. recalls HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally…
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
FDA · DeviceHamilton Medical, Inc.U.S.: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware…Official notice → - 2023-05-03
- US
Hamilton Medical AG recalls HAMILTON-C6, REF: 160021
Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an…
FDA · DeviceHamilton Medical AGUS Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA,…Official notice → - 2022-11-30
- US
Hamilton Medical AG recalls Hamilton-C6
Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again.
FDA · DeviceHamilton Medical AGU.S. Nationwide distribution including in the states of CA, FL, GA, ID, IN,…Official notice → - 2022-07-20
- US
Hamilton Medical AG recalls HAMILTON-H900 Humidifier, Models: 950001, 950004
When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm…
Other drugs & medical recalls in the United States
- 2022-08-31
- 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
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…
FDA · DeviceGetinge Usa Sales IncWorldwide distribution. US nationwide, Poland, Spain, France, Germany, Czech…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
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 → - US
Midlab Incorporated recalls Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%)128 Fl. Oz. (1 Gal.) 3.78 liters bottles, Southern…
CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
- US
Family Dollar Stores, Llc. recalls QP COUGH COLD TABLET 16 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.