# FDA recall Z-1326-2021

> **Philips North  America, LLC** · Class II · device recall initiated 2021-03-23.

## 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

## Reason for recall

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

## Distribution

International distribution in the country of China.

## Key facts

- **Recall number:** Z-1326-2021
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-23
- **Report date:** 2021-04-07
- **Termination date:** 2023-09-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1326-2021

## Citation

> AI Analytics. FDA recall Z-1326-2021. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-1326-2021. Source: US FDA. Licensed CC0.

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