CLASS II ONGOING Device recall · Reported 26 Aug 2026 · FDA Enforcement Report
Getinge Y Sensor Module, Servo-u, Servo recalled
Maquet Critical Care AB is recalling Getinge Y Sensor Module, Servo-u, Servo-n, distributed nationwide in the US. The recall was initiated on 30 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2963-2026
- FDA event ID
- 99439
- Recalling firm
- Maquet Critical Care AB, Solna
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jun 2026
- FDA classified
- 14 Aug 2026
- Reported
- 26 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 30 Jun 2026 | Recall initiated by company | |
| 14 Aug 2026 | Classified by FDA | +45 days |
| 26 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The module did not undergo electrical safety tests and functional tests during production.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.
Where it was distributed
US Nationwide distribution in the states of CA, GA, MN, NY.
Questions about this recall
Why was it recalled?
The module did not undergo electrical safety tests and functional tests during production.
Which lots are affected?
DUI/DI 07325710000304, Serial/Lot Numbers: 21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115.
Where was it sold?
US Nationwide distribution in the states of CA, GA, MN, NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Maquet Critical Care AB
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS I | Servo-u MR Ventilator System recalled by Maquet Critical Care AB | Maquet Critical Care AB | Labeling Errors | Nationwide |
| Device | CLASS I | Servo-n Ventilator System recalled by Maquet Critical Care AB | Maquet Critical Care AB | Labeling Errors | Nationwide |
| Device | CLASS I | Servo-u Ventilator System recalled by Maquet Critical Care AB | Maquet Critical Care AB | Labeling Errors | Nationwide |
Other CPAP & Ventilators recalls
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| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |