Draeger Medical, Inc. recalls Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas…
Read the official notice →- Date
- 2022-01-26
- Country
- United States
- Brand
- Draeger Medical
- Product
- Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
- Classification
- Class II
- Units
- US Nationwide distribution in the states of NY, PA, and WI.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Draeger Medical recalls
- 2023-07-19
US
Draeger Medical, Inc. recalls Oxylog 3000 Plus emergency and transport ventilator
Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.
FDA · DeviceDraeger Medical, Inc.Distributed Nationwide. OUS Distribution: Afghanistan, Algeria, Andorra,…Official notice →- 2023-05-24
US
Draeger Medical, Inc. recalls VentStar Basic (P)180, MP00351
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 2023-03-01
US
Draeger Medical, Inc. recalls NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
- 2022-06-22
US
Draeger Medical, Inc. recalls Drager SafeStar 55, Catalog No. MP01790
Possible occlusion of filters due to manufacturing error.
FDA · DeviceDraeger Medical, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice →- 2022-04-13
US
Draeger Medical, Inc. recalls Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog…
Cybersecurity Improvement Action-not equipped against potential cyber security threats
- 2021-10-20
US
Draeger Medical, Inc. recalls Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up…
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
Other drugs & medical recalls in the United States
- 2022-01-26
US
Gentueri Inc recalls Gentueri Viral Transport Medium (VTM), Sterile, IVD
Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.
US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice →US
Greiner Bio-One North America, Inc. recalls greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs.,…
Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
FDA · DeviceGreiner Bio-One North America, Inc.Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was…Official notice →US
Konica Minolta Healthcare Americas, Inc. recalls ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on…
lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incorrect length measurement/area calculation if incorrect power sequence is followed
US
Siemens Medical Solutions USA, Inc recalls 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis…
Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain…
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution in the states of AK, AL, AR, AZ, CA, FL, GU, HI,…Official notice →US
Luminex Corporation recalls ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Impacted lot may leak inside the ARIES instrument.
FDA · DeviceLuminex CorporationWorldwide distribution - US Nationwide distribution in the states of Alabama,…Official notice →