FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2337-2020
- 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.
- Status
- Terminated
- Initiated
- 2020-05-19
- Posted
- not on file
- Terminated
- 2020-08-25
- 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.
- Lot, serial or model codes
- Serial Number USPP000004
- 510(k) numbers
- K090483
- PMA numbers
- not on file
- Product code
- DPS
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28