| 2026-05-08 |
Class I
|
Ongoing |
Z-2359-2026 |
Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M109… |
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Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the inten… |
| 2026-05-08 |
Class I
|
Ongoing |
Z-2358-2026 |
Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Pro… |
— |
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the inten… |
| 2026-05-08 |
Class I
|
Ongoing |
Z-2357-2026 |
Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 20826… |
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Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the inten… |
| 2024-07-12 |
Class I
|
Ongoing |
Z-0084-2025 |
Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY … |
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Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. |
| 2024-07-12 |
Class I
|
Ongoing |
Z-0083-2025 |
Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilat… |
— |
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. |
| 2024-07-12 |
Class I
|
Ongoing |
Z-0082-2025 |
Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to p… |
— |
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. |
| 2024-07-12 |
Class I
|
Ongoing |
Z-0081-2025 |
Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patie… |
— |
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. |
| 2024-07-12 |
Class I
|
Ongoing |
Z-0080-2025 |
Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and v… |
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Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. |
| 2024-07-12 |
Class I
|
Ongoing |
Z-0079-2025 |
Amingo. OUS only. |
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Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. |
| 2024-07-12 |
Class I
|
Ongoing |
Z-0078-2025 |
Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to pati… |
— |
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. |
| 2024-07-12 |
Class I
|
Ongoing |
Z-0077-2025 |
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support t… |
— |
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. |
| 2024-07-12 |
Class I
|
Ongoing |
Z-0076-2025 |
Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support t… |
— |
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. |
| 2024-07-12 |
Class I
|
Ongoing |
Z-0075-2025 |
Aespire 100. 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. |
| 2024-07-12 |
Class I
|
Ongoing |
Z-0074-2025 |
Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to… |
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Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. |
| 2023-12-29 |
Class I
|
Ongoing |
Z-0776-2024 |
EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model … |
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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… |
| 2023-12-29 |
Class I
|
Ongoing |
Z-0775-2024 |
EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002 |
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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… |
| 2023-12-29 |
Class I
|
Ongoing |
Z-0774-2024 |
EVair air compressor, model numbers: M1230849 and M1230847 |
— |
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… |