The Recall Desk
HighFDA (Devices)·Z-0110-2015·Announced 2014-10-29

Mortara Surveyor S12 and S19 Patient Monitors Recalled for Mounting Hazard

Mortara Instrument is recalling 624 Surveyor S12 and S19 patient monitors due to a potential safety hazard when mounted with non-standard screws.

What this means for you

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 source describes a 'hazardous situation' without reporting specific injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Mortara Instrument, Inc. is recalling 624 units of the Surveyor S12 and Surveyor S19 Patient Monitors. These prescription devices are used by healthcare professionals to monitor vital signs in adult and pediatric patients, including blood pressure, respiration, temperature, and ECG.

The recall is due to a potential safety hazard that may occur when mounting the monitors using the 75mm VESA mounting hole pattern in the battery cover. The hazard is associated with the use of mounting screws that are not provided by Mortara and are longer than the specified length, which could create a hazardous situation.

The affected units were distributed nationwide in the US and internationally to 21 countries. Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice and contact Mortara Instrument for instructions on how to proceed.

The recalled product

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), Tempe
Affected units
624

Distribution

Distributed nationwide across the United States.

The notice also names 28 states specifically:

Same manufacturer · Mortara Instrument, Inc

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