| 2025-01-14 |
Class II
|
Ongoing |
Z-1066-2025 |
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitor… |
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Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient. |
| 2024-05-13 |
Class II
|
Ongoing |
Z-2189-2024 |
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23 |
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Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. He… |
| 2023-05-16 |
Class II
|
Ongoing |
Z-1992-2023 |
Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1… |
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The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values. |
| 2023-04-05 |
Class II
|
Ongoing |
Z-1472-2023 |
Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory… |
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The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirement… |
| 2023-04-05 |
Class II
|
Ongoing |
Z-1471-2023 |
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the h… |
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The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirement… |
| 2022-05-20 |
Class II
|
Ongoing |
Z-1365-2022 |
Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system |
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The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the w… |