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Recall Observatory FDA recall evidence

Device product

CLEO Patient Monitor /Tranquility VS Patient Monitor

Z-1926-2019

May 31, 2019

Class II

Product summary

Firm
Infinium Medical, Inc
Event
Event 82999
Status
Ongoing
Classification
Class II
Quantity
95 devices
Official record key
device-enforcement:Z-1926-2019

Official wording

Reason: The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.

Code information: 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, A17024800046, A17024800048, A17024800050, A17024800009, A17024800014, A17024800015, A17024800016, A17024800017, A17024800019, A17024800020, A17024800025, A17024800026, A17024800027, A17024800029, A17024800033, A17024800034, A17024800037, A17024800038, A17024800040, A17024800042, A17024800044, A17024800047, A17024800049.

Distribution pattern: Distributed nationwide to California, Georgia, Louisiana, Florida, Maryland, Minnesota, Puerto Rico, South Carolina, Virginia, Wisconsin.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.