FDA Device recall Z-1926-2019
CLEO Patient Monitor /Tranquility VS Patient Monitor
- FDA Device
- Class II
- ongoing
- Published 2019-07-10
On 2019-07-10 the FDA classified a Class II recall of CLEO Patient Monitor /Tranquility VS Patient Monitor by Infinium Medical, citing the CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1926-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-05-31 |
| Published | 2019-07-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Infinium Medical |
| Distribution | US |
Product
CLEO Patient Monitor /Tranquility VS Patient Monitor
Reason
The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.
Identifiers
| code_info | Serial Numbers - A18094501812, A18014501391, A18014600053, A18014600070, A18014600080, A18014501432, A18014501438, A170…Serial Numbers - A18094501812, A18014501391, A18014600053, A18014600070, A18014600080, A18014501432, A18014501438, A17074501202, A17084501263, A17024500996, A16054500521, 45000082, 45000084, 45000085, 45000057,45000058, A1 8094501659, A17044501052, A17024500972, A160104500653, A160104500674, A160104500685, A160104500701, A16084500604, A16084500605, A15104500320, A15 104500407, A15104500257, 45000083, 45000043, 45000044, 45000045, A17024500996, A18094501642, A18094501674, A18094501696, A17074501227, 45000072, 48000001, 48000002, 48000003, A1 8094501639, A18094501652, A18094501657, A18094501702, A18094501719, A18044600082, A18044600083, A18044600087, A18044600089, A18044600092, A17124501378, A17124501384, A17124501385, A17124501386, A17124501387, A17024800002, A17024800004, A17024800006, A17024800007, A17024800008, A17024800012, A17024800013, A17024800018, A17024800021, A17024800022, A17024800024, A17024800028, A17024800030, A1702480003 1, A17024800032, A17024800039, A17024800043, A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1926-2019%22
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