International safety notice
Sistema para hipertermia Norm-O-Temp, modelos: • 111Z: Partes 86153 (111Z, 100V), 86154 (111Z, 115V), • 111W: Partes 86156 (111 W, 100V), 86157 (111W, 115V), 86158 (111w, 230V), 86161 (111W, 240V).
Spain / AEMPS · ESP · Oct 16, 2019
Key facts
| Title | Sistema para hipertermia Norm-O-Temp, modelos: • 111Z: Partes 86153 (111Z, 100V), 86154 (111Z, 115V), • 111W: Partes 86156 (111 W, 100V), 86157 (111W, 115V), 86158 (111w, 230V), 86161 (111W, 240V). |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | Sistema para hipertermia Norm-O-Temp, modelos: • 111Z: Partes 86153 (111Z, 100V), 86154 (111Z, 115V), • 111W: Partes 86156 (111 W, 100V), 86157 (111W, 115V), 86158 (111w, 230V), 86161 (111W, 240V). |
| Manufacturer | Gentherm Medical, LLC., Estados Unidos. |
| Models | 719-3262, 113-0001N, 57425, 091-N6646, 12011, 56430, 86156, 193-N7940, 59425, 57127, 86157, FA2019-005 and 20 more |
| Event type | Safety Notice |
| Date | Oct 16, 2019 |
At a glance
- No Recall
- Yes Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1