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Terminated

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 Recall Z-2337-2020 · Posted None

Recalling FirmPhilips North America, LLC
Recall StatusTerminated
Product CodeDPS
Date Initiated2020-05-19
Date Terminated2020-08-25
Product Quantity1

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution including in the state of NJ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090483SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORSPhilips Medical Systems · 2009-03-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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