FDA Medical Device Recalls (openFDA)
Philips North America, LLC: Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086) SureSi"gns VM8 (863066, 863068, 863087, 863088) Model Numbers: 863063,863064,863065,863066,863068,863085,863086, 453564021961,453564021971, 53564022001,453564022041, 53564022081,453564024371, 453564024401,453564024421 453564024441,453564024461, 453564024481
- Recall number
- Z-1326-2021
- Recalling firm
- Philips North America, LLC
- Product
- Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086) SureSi"gns VM8 (863066, 863068, 863087, 863088) Model Numbers: 863063,863064,863065,863066,863068,863085,863086, 453564021961,453564021971, 53564022001,453564022041, 53564022081,453564024371, 453564024401,453564024421 453564024441,453564024461, 453564024481
- Status
- Terminated
- Initiated
- 2021-03-23
- Posted
- not on file
- Terminated
- 2023-09-28
- Reason
- Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Range/accuracy of heart rate meter for pediatric mode-In pediatric mode, when the input signal rate is over 300 bpm, the indicated rate of the affected products will be lower than this upper limit
- Root cause
- Software design
- Action
- Philips Market Organizations are responsible for distributing the letters outside of the U.S. Letter issued on 3/23/21 , stating: Reason for correction, health risk and Action to be Taken by Customer/User states: This issue only happens on pediatric type patient with heartrate is greater than device claimed maximum heart rate 300 bpm. The device can continue to be used, however when using the monitor in the Pediatric category, patients at risk for tachycardia should be kept under close observation in accordance with existing product warnings described in the IFU. You may also consider to keep the default HR alarm limits or set tight HR alarm limits around the patients baseline HR for these patients Philip will send an engineer onsite to check the SW revision of your monitors. PHILIPS Subsequently a SW upgrade will be performed if your device is with the affected software revision. A Philips Healthcare representative will contact you to arrange for the correction.
- Quantity
- 31773 units
- Distribution
- International distribution in the country of China.
- Lot, serial or model codes
- Software version: SW A.02.63
- 510(k) numbers
- ["K123900"]
- PMA numbers
- not on file
- Product code
- MHX
- 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