Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for use in adult & pediatric p
FDA device recall Z-0110-2015 · posted 2014-10-22 · Terminated
Recall details
- Recalling firm
- Mortara Instrument, Inc
- 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
- Action taken
- Mortar Instruments, Inc. sent an "Urgent Medical Device Correction" letter dated October 3, 2014. The letter was addressed to Health Care Administrator / Risk Manger and Director of Biomedical / Clinical Engineering.The letter described the problem and the product involved in the recall. Customers were advised to contact Mortara Technical Support at 1-888-667-8272 or TechSupport @mortara.com to schedule a service representative to update their Surveyor S12 and Surveyor S19 units or for additional questions they can contact their local Service Representative. The update will include replacement of the battery cover and replacement of the battery pack if mounting screw damage is evident. International consignees received similar dated letter except it provided instructions detailing the correction steps and requested customers to complete and return the Response Acknowledgement and Receipt Form. For questions they can contact Technical Support at +1.414.354.1600 or TechSupport@mortara.com, or contact your local Service Representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 624
- 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: AUST
- Date initiated
- 2014-10-07
- Date posted
- 2014-10-22
- Date terminated
- 2015-02-13
- Location
- Milwaukee, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MORTARA SURVEYOR PATIENT MONITOR (K123556) | Mortara Instrument, Inc. | 2013-03-22 |