Recall record at a glance
| Official record | Z-0110-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Mortara Instrument, Inc. |
| Report date | Oct 29, 2014 |
| Recall initiation date | Oct 7, 2014 |
| Quantity | 624 |
| Location | Milwaukee, WI, United States |
Official 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.
Why the product was recalled
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
Distribution information
Worldwide Distribution: US (Nationwide) in the states of: AZ, AR, CA, DC, FL, ID, IL IN, KY, LA, ME, MD, MA, MI, MN, MO, MT, NV, NJ, NY, NC, OK PA, SC, TN, TX, VA, and WI; and internationally to: AUSTRALIA, BANGLADESH, CANADA, CHILE, CROATIA, EGYPT, GERMANY, ITALY, JORDAN, LEBANON, MALAYSIA, MOROCCO, OMAN, PHILIPPINES, POLAND, ROMANIA, SAUDI ARABIA, THAILAND, THE NETHERLANDS, UNITED KINGDOM.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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