Surepulse Medical Limited

Code	Device name	Class	Specialty	Clearances	Most recent
DQA	—	—	—	1	2021-07-23

Date	Severity	Status	Recall #	Product	Code	Reason
2023-01-20	Class III	Ongoing	Z-1360-2026	Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor	—	Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
2023-01-20	Class III	Ongoing	Z-1359-2026	Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor	—	Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
2023-01-20	Class III	Ongoing	Z-1358-2026	Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor	—	Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
2023-01-20	Class III	Ongoing	Z-1357-2026	Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor	—	Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
2023-01-20	Class III	Ongoing	Z-1356-2026	Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor	—	Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Date	K-number	Device	Code	Class	Specialty
2021-07-23	K201887	VS Newborn Heart Rate Monitor	DQA	—	—

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