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.
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 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)…
- Manufacturer
- Mortara Instrument, Inc
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 624
Distribution
Related recalls
Same manufacturer · Mortara Instrument, Inc
See all →- HighMortara ELI 380 Electrocardiograph Recalled for Patient Data Mismatch Risk
FDA (Devices) · 2015-06-24
Other medical device recalls
- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateWelch Allyn Surveyor Bedside Patient Monitor Recalled for Safety Standard Non-Compliance
FDA (Devices) · 2021-04-28
- HighWelch Allyn Surveyor S12 and S19 Patient Monitors Recalled for Defibrillation Safety
FDA (Devices) · 2020-05-06
- HighMediana Attendant Vital Signs Monitor Recalled for Temperature Measurement Failures
FDA (Devices) · 2020-07-08
- HighMediana Vital Signs Monitor May Fail to Power Up or Respond
FDA (Devices) · 2021-07-28
- HighMindray Recalls Passport V Monitors Due to Inaccurate Blood Pressure Readings
FDA (Devices) · 2015-03-25
- HighMindray Recalls V Series Patient Monitors Due to Software Anomalies
FDA (Devices) · 2012-09-05