Recall Z-1096-2014
Invivo Corporation · initiated October 3, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Information Portal (Model IP5) a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professional to remotely monitor the vital signs of patients undergoing MRI procedures. Available monitoring from the IP5 can include ECG, SpO2, non-invasive and invasive blood pressure, CO2, respiration, anesthetic agents, gases, and temperature parameters.
Codes / lots: US23200113, US23200120, US23200121, US23200122, US23200123, US23200124, US23200125, US23200126, US23200127, US23200128, US23200129, US23200130, US23200131, US23200132, US23200133, US23200134, US23200135, US23200136, US23200137, US23200138, US23200139, US23200140, US23200141, US23200142, US23200143, US23200144, US23200145, US23200146, US23200147, US23200148, US23200149, US23200150, US23200151, US23200152, US23200153, US23200154, US23200155, US23200156, US23200157, US23200158, US23200159, US23200160, US23200161, US23200162, US23200163, US23200164, US23200165, US23200166, US23200167, US23200168, US23200169, US23200170, US23200172, US23200173, US23200176, US23200177, US23200178, US23200179, US23200180, US23200181, US23200182, US23200183, US23200184, US23200185, US23200186, US23200187, US23200188, US23200189, US23200190, US23200191, US23200192, US23200193, US23200194, US23200195, US23200196, US23200197, US23200198, US23200199, US23200200, US23200201, US23200202, US23200203, US23200204, US23200205, US23200206, US23200207, US23200208, US23200209, US23200210, US23200211, US23200212, US23200213, US23200214, US23200215, US23200216, US23200217, US23200218, US23200219, US23200220…
Reason for recall
Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling their Expression Information Portal (Model IP5). Three different IP5 devices lost audio during use.
FDA-determined cause: Software design
Action taken
Philips Healthcare sent an "URGENT - MEDICAL DEVICE RECALL" letter dated October 3, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to refer to the "Action to be Taken by Customer/User section on the attached pages. A Philips representative will contact the customer regarding their affected devices. All affected devices will have a software update installed in order to correct the problem free of charge. Contact your local Philips representative for further information and support.
Details
- Recall number
- Z-1096-2014
- Initiated
- October 3, 2013
- Posted by FDA
- February 26, 2014
- Terminated
- September 12, 2016
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Quantity
- 271
- Distribution
- Worldwide Distribution - USA and the countries of Australia, Austria, Denmark, France, Germany, Netherlands, Poland, Singapore, Sweden, Switzerland, United Kingdom.
- Recalling firm
- Invivo Corporation, Orlando, FL