Device product
Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram.
Z-1350-2015
Product summary
- Event
- Event 70704
- Status
- Terminated
- Classification
- Class II
- Quantity
- 364,800
- Official record key
device-enforcement:Z-1350-2015
Official wording
Reason: The electrodes may fail to transmit signals.
Code information: FS-50 Lot: 40120-0093 FS-50 Lot: 40117-0091 FS-50 Lot: 40116-0099 T -60 Lot: 40116-0323 T-60 Lot: 40120-0326 T -60 Lot: 40120-0154 T -60 Lot: 40117-0325 T -60 Lot: 40117-0153 T -60 Lot: 40116-0152 T -60 Lot: 40115-0322
Distribution pattern: Distributed to FL.
Derived failure modes
-
Unknown
The electrodes may fail to transmit signals.