Recall Z-2337-2020 ยท DPS Electrocardiograph
Philips North America, LLC
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.
| Date | May 19, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 1 |
| Distribution | US Nationwide distribution including in the state of NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090483 | SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS Philips Medical Systems, Mar 20, 2009 |