The system provides the ability to transmit patient data files for storage, viewing and analysis at
Medical device recall Z-2760-2016. Published in FDA’s Enforcement Report on Sep 14, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 14, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 49 states named
- 2,929 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
2,929, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product: Xper Flex Cardio Patient Monitoring System Model Numbers FC2010 and FC2020 Serial Numbers by Product: 453564241901 USI203010414 USI244000011 USI234000052 USI521000021 USI343000067 USI343000030 USI337000084 USI334000030…
Every code shown here, 1,991 characters
Product: Xper Flex Cardio Patient Monitoring System Model Numbers FC2010 and FC2020 Serial Numbers by Product: 453564241901 USI203010414 USI244000011 USI234000052 USI521000021 USI343000067 USI343000030 USI337000084 USI334000030 USI331000048 US 1328000004 USI324000049 USI324000017 USI319000088 US1319000043 USI319000016 USI251000082 USI251000054 USI251000042 USI251000007 USI25000054 USI248000041 USI234000090 USI224000028 USI203010318 USI202010188 USI343000053 USI251000005 USI231000001 US1334000034 USI334000018 USI319000053 USI234000045 us 1343000064 us 1343000018 us 1334000026 us 1334000008 USI324000025 USI311000001 USI239000005 USI234000054 USI224000026 USI203010419 USI203010418 USI203010411 USI203010403 USI203010391 US1203010372 USI203010301 US120301 0256 USI20201 0209 USII0701 0022 USI343000015 USI334000028 USI319000077 USI337000059 US1337000022 USI33!000014 USI319000087 USI319000061 US1319000002 USI244000002 USI239000049 USI203010392 USI203010264 US1201010131 USI109010102 USII08010061 USII08010051 USI319000034 USI319000071 USI311000015 USI203010326 US1203010289 US1109010105 USI337000014 USI234000065 USII08010062 USI319000046 USI324000021 USI2440000043 US1203010306 USI251000040 USI343000076 USI343000055 US 1337000010 US 1337000004 USI331000055 US 1319000070 USI319000042 US1311000051 USI251000073 USI239000036 USI234000060USI234000043 USI231000063 USI203010424 USI203010312 USI203010292 USI343000074 USI343000045 us 1343000040 us 1343000038 us 133 7000073 us 1337000069 USI337000001 USI324000037 USI319000086 USI311000061 USI251000076 USI251000057 USI248000079 USI234000058 US 1234000025 USI231000089 USI224000008 US 1203010417 USI203010331 USI203010302 USI203010250USI202010242 USI202010171 USI201010122 USII09010065 USI343000054 USI239000024 USI2440000019 USI23000048 USI201010120 us 1331000045 us 1343000070 us 1343000062 us 1343000048 USI343000047 USI337000072 USI337000044 USI337000013 USI337000012 USI337000002 USI334000029 USI334000013 US 1334000003 USI331000060…
FDA’s list runs to 36,302 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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, WI, WV, Alaska, Hawaii, & Washington, DC. Worldwide Distribution to the countries of : Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Canada, Cayman Islands, Chile, Columbia, Croatia, Democratic Republic of Congo, Denmark, Ecuador, Egypt, Estonia, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Republic of Korea, Lebanon, Libya, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, State of Palestine, Panama, Papua New Guinea, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Taiwan Province, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, United Republic of Tanzania, Uzbekistan, & Vietnam.
The states and territories these words name
49 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 19, 2015.
- FDA classified it on Sep 8, 2016.
- FDA’s Enforcement Report published it on Sep 14, 2016.
- FDA terminated it on Oct 4, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Invivo Corporation, of Orlando, FL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 36,302 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.