SenTec Digital Monitor Recalled for Missing Isolation Transformer Requirement
SenTec AG is recalling 15 SenTec Digital Monitors because they require an isolation transformer in home care settings to meet safety standards.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves compliance with safety standards regarding electrical isolation in home settings, which fits the criteria for moderate severity without reported injuries.
Plain-English summary
SenTec AG is recalling 15 units of the SenTec Digital Monitor, Model SDM. This portable stand-alone patient monitor is used for continuous, noninvasive monitoring of carbon dioxide partial pressure, oxygen partial pressure, functional oxygen saturation, and pulse rate. The recall is being conducted because the device requires the use of an isolation transformer in combination with the SDM in home care settings to comply with applicable safety standards.
The affected devices were distributed in Illinois, Pennsylvania, Florida, New Jersey, Georgia, and Massachusetts. The specific serial numbers for the recalled units are 303170, 311263, 311166, 311408, and 303426. The serial number information is current as of the date of the recall notice.
Consumers and healthcare providers should check their devices against the listed serial numbers. If a device is affected, it should be used only with an isolation transformer in home care settings to ensure compliance with safety standards.
The recalled product
- Product
- SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a
- Manufacturer
- SenTec AG
- Category
- Medical Device — Patient Monitor
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Serial Numbers: 303170
- 311263
- 311166
- 311408
- 303426* *serial number information current as of today's date
Distribution
Related recalls
Same manufacturer · SenTec AG
See all →- ModerateSentec Membrane Changer components recalled for manufacturing defect
FDA (Devices) · 2023-09-27
- ModerateV-Sign Sensor 2 May Experience Out-of-Box Failure Due to Software Configuration
FDA (Devices) · 2023-06-28
- HighTranscutaneous monitor attachment rings recalled for weak skin adhesion
FDA (Devices) · 2022-11-09
- HighSenTec Neonatal Starter Set Recalled for Potential Electrolyte Application Defect
FDA (Devices) · 2019-08-14
- HighSenTec Membrane Changer Recall Due to Electrolyte Application Defect
FDA (Devices) · 2019-08-14
Same hazard · electrical safety
See all →- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
- ModerateSpacelabs SL Command Module patient monitor recall due to manufacturing defect
FDA (Devices) · 2026-05-13
- High
- High
- ModerateMRI systems recalled over electrode spacing below the required safety standard
FDA (Devices) · 2025-11-05