Heartsine Technologies, Limited
Heartsine Technologies, Limited appears in FDA public data with 2 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2115-2014, Class II) was initiated on June 12, 2014.
Summary
- Total Recalls
- 2 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2115-2014 | Class II | Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and | June 12, 2014 |
| Z-0124-2013 | Class I | HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A0003500 | September 13, 2012 |