The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.

Recall Insight

This FDA Devices action (record #Z-2760-2016) was formally reported on September 14, 2016, with the manufacturer initiating the action on October 19, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Invivo Corporation is listed as the recalling firm, operating out of Orlando, FL. Federal records indicate 2,929 units are affected.

The documented reason for this recall is: Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze Distribution data in the federal record shows the product reached: Nationwide Distribution to the states of :AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TX, TN, UT, VA, WA, W…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.