Draeger Medical, Inc. recalls Dr¿ger Perseus A500 Anesthesia Workstation
Unexpected shutdown while operating on battery power.
Read the official notice →- Date
- 2024-04-24
- Country
- United States
- Brand
- Draeger Medical
- Product
- Dr¿ger Perseus A500 Anesthesia Workstation
- Classification
- Class I
- Units
- Domestic: Nationwide Distribution; Foreign: Angola, Argentina, Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-12-25
USDraeger Medical, Inc. recalls Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in…
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
FDA · DeviceDraeger Medical, Inc.No Atlan A300 or A300XL devices were imported into the US. Devices were direct…Official notice →- 2024-11-20
- US
Draeger Medical, Inc. recalls Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
FDA · DeviceDraeger Medical, Inc.US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY,…Official notice → - 2023-08-30
- US
Draeger Medical, Inc. recalls Carina Sub-Acute Care Ventilator
Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.
- 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.
Other drugs & medical recalls in the United States
- 2024-04-24
- US
Cook Incorporated recalls Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into…
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
FDA · DeviceCook IncorporatedWorldwide distribution - US Nationwide and the countries of AT, AU, BR, CA,…Official notice → - US
Baxter Healthcare Corporation recalls Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021,…
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate…
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Canada, Ireland,…Official notice → - US
SonarMed Inc recalls AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
The failure to detect the partial obstruction in a 2.5mm sensor.
FDA · DeviceSonarMed IncDomestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX,…Official notice → - US
Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
FDA · DevicePhilips Respironics, Inc.Domestic: Nationwide Distribution; Foreign: AE, AR, AT, AU, BD, BE, BG, BO,…Official notice → - US
Outset Medical, Inc. recalls Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that…
FDA · DeviceOutset Medical, Inc.US:FL, CA, NM, SC, AZ, TN, NC, TX, IL, MD, IN, DE, AL, MI, AK, KY, LA, ID, OK,…Official notice → - US
Elekta Instrument AB recalls Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes…
Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same…
FDA · DeviceElekta Instrument ABUS and Australia, Austria, Belgium, France, Germany, Greece, Italy,…Official notice →