| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01108-1 |
| Product Name/Description |
Surveyor S12 and Surveyor S19 Patient Monitors
Multiple part numbers and serial numbers affected
Manufactured March, 2012 to September, 2014
ARTG Number: 215421 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving Surveyor S12 and Surveyor 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 provided screws, it is possible for the longer screws to be driven completely through the battery cover and then possibly penetrate the protective casing of the lithium-ion battery which may result in a fire. There have been no reported incidents of fire, injury or death due to this potential safety hazard. A correction has been developed to eliminate the potential risk. The
correction alters the design of the battery cover, creating a barrier that prevents mounting screws from penetrating into the battery compartment. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Mortara Instrument Australia service representative will be contacting affected customers to schedule an update that includes replacement of the battery cover and replacement of the battery pack if mounting screw damage is evident. This update is at no cost to the customer. This action has been closed-out on 1/03/2016. |
| Contact Information |
02 8070 9303 - Mortara Service Representative |