Recall Z-0468-2013 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Invivo Corporation
Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner.
| Date | Dec 4, 2012 (initiated Oct 15, 2012) |
| Status | Terminated |
| Reason | Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression MRI Patient Monitoring System because during transport of the systems cart with a docked Display Controller Unit (DCU), a caster (wheel) may become detached. If this occurs, the cart can become unbalanced and may fall. |
| Root cause | Nonconforming Material/Component |
| Action | Philips Healthcare sent an "URGENT-MEDICAL DEVICE RECALL" letter dated October 15, 2012 to all affected customers. The letter identified the product, problem, and actons to be taken by the customers. Customers were instructed to inspect all casters of the unit to ensure that they are all secured. If a caster is loose, customers were told to lock the caster in place, limit movement of the cart and contact their local Phillips Invivo Representative. Nevertheless, a Philips Invivo representative will contact the customer regarding their affected device. All affected devices will have new caste |
| Quantity | 543 units |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of MO; MS; MA; IL; OH; NY; KS; PA; WI; VA; SD; AZ; FL; OR; TX; MA; MO; FL; MA; MI; CT; CA; NJ; NC; ME; IL; MA; MA; WV; MA; MN; CA; AL; AL; WI; DC; OH; WV; CA; NC; NY; MT; NJ; CA; WA; IN; MI; PA; TX; NC; TN; TX; ID; NM; IL; PA; IN; IL; WA; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090785 | MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 Invivo Corp., Dec 15, 2009 |