Recall Z-0110-2015— Mortara Instrument, Inc
Class II · Terminated
Class II FDA medical device recall by Mortara Instrument, Inc, initiated 2014-10-07, terminated 2015-02-13. It names one FDA 510(k) clearance: K123556. Product: Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood pressure (NIBP), Impedance respiration, Invasive blood pressure (P1-P4), Temperature, Functional arterial oxygen saturation (SpO2), End-tidal & inspired CO2, ECG monitoring with arrhythmia and ST-segment analysis, 12-Lead resting ECG, Cardiac output (C)). The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.. Reason: Martara Instrument, Inc. has recently became aware of a potential safety hazard involving our Surveyor rand S12 S19 Patient Monitors. A hazardous situation may be created when mounting these monitors using the 75mm VESA mounting hole pattern provided in the battery cover of these monitors. If the mounting screws provided by Mortara are not used and if the mounting screws used are longer than the p.
- Recalling firm
- Mortara Instrument, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-07
- Terminated
- 2015-02-13
- Firm location
- Milwaukee, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood pressure (NIBP), Impedance respiration, Invasive blood pressure (P1-P4), Temperature, Functional arterial oxygen saturation (SpO2), End-tidal & inspired CO2, ECG monitoring with arrhythmia and ST-segment analysis, 12-Lead resting ECG, Cardiac output (C)). The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
Reason for recall
Martara Instrument, Inc. has recently became aware of a potential safety hazard involving our Surveyor rand S12 S19 Patient Monitors. A hazardous situation may be created when mounting these monitors using the 75mm VESA mounting hole pattern provided in the battery cover of these monitors. If the mounting screws provided by Mortara are not used and if the mounting screws used are longer than the p
Data sourced from openFDA. This site is unofficial and independent of the FDA.