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 arter
Check against the official notice below — it lists the full affected range.
Mortara Instrument, Inc. is recalling Surveyor S12 and Surveyor S19 Patient Monitors used for monitoring adult and pediatric patients. The monitors have a potential safety hazard related to their 75mm VESA mounting hole pattern on the battery cover. A hazardous situation may occur if mounting screws other than those provided by Mortara are used, particularly if the screws are longer than specified. A total of 624 units are affected, with specific serial numbers identified in the recall. The devices were distributed nationwide across 27 U.S. states and internationally to 20 countries including Canada, the United Kingdom, Australia, and various nations in Europe, Asia, and the Middle East.
The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Distribution: 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. Quantity: 624 Lot/code info: Unit Serial Number 113400177138 113400177139 114260218985 114260218986 114260218987 114360228306 114330225509 114330225510 114330225511 114330225512 114330225513 114330225514 114330225515 114330225516 113430180113 114100196465 114040191976 114090196324 113490185858 113490185860 112090110348 113030149744 113030149745 113460182773 113460182774 113460182775 113460182776 113460182777 113460182778 113460182779 113460182780 113460182781 113460182782 113460182783 113460182784 113460182785 113460182786 113470184344 112090110349 112090110359 112090110360 112100110533 112100110538 112480143971 112480143973 112480143974 112490144251 112490144252 112490144253 112490144254 112490144255 113030149224 113030149746 113030149747 113030149748 113030149749 113030149750 113110157148 113110157149 113230166552 113230166553 113230166554 113230166555 113230166556 113230166557 113280169582 113300171794 113300171795 113450181352 113450181353 113450181354 113450181355 113450181497 113450181498 113450181499 113450181500 113450181501 113450181502 113450181640 113450181641 113450181642 113450181643 113460182680 113460182681 113460182682 113460182683 113460182684 113460182685 113460182768 113460182769 113460182770 113460182771 113470184286 113470184290 113470184291 113490185852 113490185853 113490185857 114100200986 114150205554 114150205559 114150205560 114150205561 114180209641 114230216030 114230216031 114230216032 114230216033 114230216189 114230216190 114270220481 114270220482 114270220483 114270220484
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.