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.
This recall has been terminated (originally issued May 19, 2020).
- Company
- Philips North America, Llc
- Recall Initiated
- May 19, 2020
- Terminated
- August 25, 2020
- Recall Number
- Z-2337-2020
- Quantity
- 1
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Philips has identified a Philips SureSigns VM1 monitor in the possession of a clinical user that was not intended for commercial distribution and for which Philips does not have records regarding its manufacture. Philips is therefore removing this device from distribution.
Distribution
US Nationwide distribution including in the state of NJ.
Lot / Code Info
Serial Number USPP000004
Root Cause
Under Investigation by firm
Action Taken
On May 19, 2020, the firm sent the affected customer an URGENT Medical Device Removal letter, informing them of the issue. The firm is unaware of any other pre-production VM1 devices in distribution. The customer was asked to immediately locate the affected unit, remove it from clinical use, and quarantine the device in a secure location. A Philips representative will contact the customer to arrange for the removal of the affected unit. Customers with questions may contact their local Philips representative or call 1-800-722-9377.