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…
Read the official notice →- Date
- 2023-05-03
- Country
- United States
- Brand
- Hamilton Medical
- Product
- HAMILTON-C6, REF: 160021
- Classification
- Class II
- Units
- US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 → - 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 → - 2022-08-31
- 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…
- 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
- 2023-05-03
- US
Baxter Healthcare Corporation recalls GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral…
The product is brittle and potentially crumbling upon handling or when being removed from its package.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of China, Germany,…Official notice → - US
ROi CPS LLC recalls Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
FDA · DeviceROi CPS LLCUS Nationwide distribution in the states of FL and MO. There was no…Official notice → - US
Aesculap Implant Systems LLC recalls Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A…
Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.
FDA · DeviceAesculap Implant Systems LLCUS Nationwide distribution in the states of CA, OH, NE, NH, FL, PA, TX.Official notice → - US
SPINEART SA recalls JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S;…
JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble during the preparation stage before implantation, or during surgery when removing the implant holder, which could…
FDA · DeviceSPINEART SAUS Nationwide distribution in the states of NH, TX, CA, VA, IL, RI, NC, AZ.Official notice → - US
Richard Wolf GmbH recalls FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a…
FDA · DeviceRichard Wolf GmbHWorldwide distribution - US Nationwide and the countries of United Arab…Official notice → - US
Carefusion 2200 Inc recalls (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Carefusion V. Mueller…
A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were switched on the two products.
FDA · DeviceCarefusion 2200 IncDistribution was made to AL, AR, AZ, CA, CO, CT, FL, HI, IA, IL, IN, KY, LA,…Official notice →