Z-2337-2020Class II

Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 -

Name: Z-2337-2020 Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 -
Creator: Philips North America, LLC
Published: 2020-05-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-05-19 / Terminated / root cause: manufacturing process

FDA source

Philips North America, LLC began a recall of Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02)... on 2020-05-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2337-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-19
Posted: 2020-06-10
Terminated: 2020-08-25
Recalling firm: Philips North America LLC
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.
Product code: DPS Electrocardiograph
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 1
Distribution: US Nationwide distribution including in the state of NJ.
Product codes and lots: Serial Number USPP000004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2337-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2337-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-10

Product code DPS

K090483Class IISursigns Vs2 Vital Signs Monitor, Suresigns Vs3 Vital Signs Monitor, Suresigns Vm Series Patient MonitorsPhilips Medical Systems / cleared 2009-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)