Z-2441-2020 Class II Terminated
FDA device recall Z-2441-2020 was initiated by Mediana Co., Ltd. on May 15, 2020 and is designated Class II. Reason for recall: Failures were found in the temperature measurement function while in the predict mode. The recall status is terminated (terminated September 16, 2022). Affected quantity: 180 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2020
- Initiation Date
- May 15, 2020
- Termination Date
- September 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 180 devices
Product Description
DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.
Reason for Recall
Failures were found in the temperature measurement function while in the predict mode.
Distribution Pattern
US Nationwide distribution.
Code Information
Serial Numbers: 456802000001~456802000180