Z-1326-2021 Class II Terminated
FDA device recall Z-1326-2021 was initiated by Philips North America, LLC on March 23, 2021 and is designated Class II. 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 i… The recall status is terminated (terminated September 28, 2023). Affected quantity: 31773 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 7, 2021
- Initiation Date
- March 23, 2021
- Termination Date
- September 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31773 units
Product Description
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 Pattern
International distribution in the country of China.
Code Information
Software version: SW A.02.63