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FDA (Device enforcement)Recalled 2014-06-30closedclass ii

Invivo Corporation: Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by tra

Is my product affected?

Philips IP5 Information Portal 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 professionals to remotely monitor the vital signs of patients undergoing MRI procedures.

  • UPC 453564251511

Check against the official notice below — it lists the full affected range.

What happened

Invivo Corporation is recalling the Philips IP5 Information Portal, a display and device controller used with Philips MRI patient monitoring systems. The wireless function of the IP5 radio could be interrupted, causing loss of wireless communication between the IP5 and the host monitoring system. A total of 573 devices have been distributed worldwide, including throughout the United States, and in Australia, Austria, Denmark, France, Germany, Ireland, Netherlands, Norway, Poland, Saudi Arabia, and Singapore.

The affected devices include product number 865471 with number 453564251511, and specific serial numbers ranging from US23200121 through US23200246 (with some numbers omitted from the sequence). The recall document does not specify a remedy or what actions affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system.

Details from the source

Reason for recall: The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system. Distribution: Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, MN, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, Hawaii, Alaska, and District of Columbia; and countries of: Australia, Austria, Denmark, France, Germany, Ireland, Netherlands, Norway, Poland, Saudi Arabia, Singapore Quantity: 573 devices. Lot/code info: Product: 865471 Number 453564251511 Serial Numbers: 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, 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, US23200221, US23200222, US23200223, US23200224, US23200225, US23200226, US23200227, US23200228, US23200229, US23200230, US23200231, US23200232, US23200233, US23200234, US23200235, US23200236, US23200237, US23200238, US23200239, US23200240, US23200241, US23200242, US23200243, US23200244, US23200245, US23200246, US232002

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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