Device product
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
Z-1356-2026
Product summary
- Event
- Event 98292
- Status
- Ongoing
- Classification
- Class III
- Quantity
- N/A
- Official record key
device-enforcement:Z-1356-2026
Official wording
Reason: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Code information: DI Number: 05060550650006/Lot: 13816/00001 13817/00001 13818/00001 13819/00001 13820/00001 13821/00001 13822/00001 13823/00001 13824/00001 13825/00001 13826/00001 13827/00001 13828/00001 13829/00001 13830/00001 13831/00001 13832/00001 13833/00001 13834/00001 13835/00001 13836/00001 13837/00001 13838/00001 13839/00001 13840/00001
Distribution pattern: Worldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates.
Derived failure modes
-
Labeling or packaging
Labeling contains incorrect