Philips SureSigns VM1 Monitor Recalled Due to Unverified Manufacturing Records
Philips is recalling a specific SureSigns VM1 patient monitor because it was not intended for commercial distribution and lacks manufacturing records.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 a voluntary precautionary action to remove a device with unverified manufacturing records that was not intended for commercial distribution. No injuries, illnesses, or specific safety hazards are reported in the source text.
Plain-English summary
Philips North America, LLC is recalling a single unit of the Philips SureSigns VM1 patient monitor, model number 863266. The device is used to measure oxygen saturation, respiration, and CO2. The recall is limited to a specific unit with serial number USPP000004.
The recall was initiated because Philips identified the monitor in the possession of a clinical user, but the device was not intended for commercial distribution. Additionally, Philips does not have records regarding the manufacture of this specific unit. As a result, the company is removing the device from distribution.
The affected device was distributed nationwide in the United States, including New Jersey. No specific instructions for consumers are provided in the source text, but the device is being removed from distribution by the manufacturer.
The recalled product
- Product
- Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02), respiration and CO2. The user interface is designed for fast and intuitive operation.
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 1
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 (1)
- Serial Number USPP000004
Distribution
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