Mediana Attendant Vital Signs Monitor Recalled for Temperature Measurement Failures
Mediana Co., Ltd. is recalling 180 Attendant Vital Signs Monitors because failures were found in the temperature measurement function while in predict mode.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a vital sign monitor used in clinical settings. While no specific injuries are reported, the potential for incorrect temperature readings in a medical device represents a risk of harm where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Mediana Co., Ltd. is recalling 180 units of the DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2. The device is used to monitor noninvasive blood pressure, functional arterial oxygen saturation, pulse rate, and temperature for adult, pediatric, and neonatal patients in hospital and hospital-type facilities.
The recall was initiated because failures were found in the temperature measurement function while the device was in predict mode. The affected devices have serial numbers ranging from 456802000001 to 456802000180.
The devices were distributed nationwide in the United States. Users should contact the recalling firm for further instructions on how to address the defect.
The recalled product
- Product
- 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…
- Manufacturer
- Mediana Co., Ltd.
- Hazard
- Affected units
- 180
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: 456802000001~456802000180
Distribution
Distributed nationwide across the United States.
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