Datex-Ohmeda, Inc. recalls Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to…
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Read the official notice →- Date
- 2024-10-30
- Country
- United States
- Brand
- Datex-Ohmeda
- Product
- Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to…
- Classification
- Class I
- Units
- Worldwide distribution - US Nationwide and the countries of Aland Islands,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Datex-Ohmeda recalls
- 2026-09-23
USDatex-Ohmeda, Inc. recalls Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling…
- 2026-06-24
- US
Datex-Ohmeda Inc recalls Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001,…
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting…
- 2024-11-06
- US
DATEX--OHMEDA, INC. recalls GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3)…
Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week.…
- 2024-10-23
- US
DATEX--OHMEDA, INC. recalls GE Heathcare Giraffe OmniBed; neo natal incubator
GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This…
- 2024-02-07
- US
Datex-Ohmeda, Inc. recalls EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstr¿m Carestation/Pro ventilators, respectively. These…
- 2023-07-12
- US
DATEX--OHMEDA, INC. recalls Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f.…
GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe…
Other drugs & medical recalls in the United States
- 2024-10-30
- US
B-K Medical A/S recalls bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery…
The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable.
FDA · DeviceB-K Medical A/SWorldwide - US Nationwide - There was also government/military distribution…Official notice → - US
Olympus Corporation of the Americas recalls Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and…
The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of…
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of AU, CA, CL, DE,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Sterile;…
Product has been identified as having holes in the packaging.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the countries of India and Panama.Official notice → - US
Baxter Healthcare Corporation recalls Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3)…
The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.
- US
Smiths Medical ASD Inc. recalls CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
- US