Infinium Medical, Inc: Medical Device Recall in 2019 - (Recall #: Z-1926-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

CLEO Patient Monitor /Tranquility VS Patient Monitor

Product Classification:

Class II

Date Initiated: May 31, 2019

Date Posted: July 10, 2019

Recall Number: Z-1926-2019

Event ID: 82999

Reason for Recall:

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

Status: Ongoing

Product Quantity: 95 devices

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.

Voluntary or Mandated:

Voluntary: Firm initiated