Recalls / —
—#181650
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.
- FDA product code
- DPS — Electrocardiograph
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K090483
- Affected lot / code info
- Serial Number USPP000004
Why it was recalled
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 (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Philips North America, LLC
- Address
- 3000 Minuteman Rd, Andover, Massachusetts 01810-1032
Distribution
- Distribution pattern
- US Nationwide distribution including in the state of NJ.
Timeline
- Recall initiated
- 2020-05-19
- Terminated
- 2020-08-25
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #181650. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.