Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (el
Check against the official notice below — it lists the full affected range.
Invivo Corporation is recalling 1,040 units of the Xper Flex Cardio physiomonitoring system in the United States and 7 units in foreign countries including Canada, China, Great Britain, and Korea. The system is used to help doctors investigate heart and blood vessel disease during invasive procedures. The recall was issued because users may accidentally close the Full Disclosure Control Window by pressing the ESC key instead of clicking the X icon in the upper right corner of the window.
The affected units include specific model numbers and serial numbers that have been distributed nationwide across most U.S. states and internationally. The source document does not specify a remedy or what affected consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window.
Reason for recall: While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window. Distribution: Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, NV, OH, PA, RI, SC, TN, TX, VA, WA, and WI ; and countries of: Canada, China, Great Britain and Korea. Quantity: 1,040 units (USA) and 7 units (Foreign) Lot/code info: MODEL #(s): 453564428541 (Service # 453564241911), 453564243601 (Service # 453564483331), 453564634211 (Service # 453564621801) SERIAL NUMBERS: US1203010251, US1239000027, US1203010279, US1203010280, US1203010308, US1203010334, US1203010346, US1203010352, US1203010358, US1203010360, US1203010366, US1203010375, US1203010398, US1203010407, US1304000043, US1304000046, US1224000050, US1550001470, US1251000063, US1109010070, US1109010072, US1109010075, US1201010130, US1331000013, US1505000507, US1343000034, US1311000042, US1337000033, US1201010112, US1201010119, US1201010120, US1201010122, US1202010171, US1202010186, US1202010202, US1203010396, US1231000007, US1231000032, US1231000050, US1231000074, US1231000090, US1234000008, US1311000016, US1311000023, US1248000071, US1708000101, US1720000441, US1550001478, US1248000065, US1729000603, US1352000006, US1352000022, US1352000044, US1352000046, US1352000048, US1107010005, US1231000060, US1537001268, US1537001272, US1537001276, US1537001277, US1537001280, US1537001338, US1202010174, US1417000023, US1419000042, US1412000038, US1419000004, US1419000023, US1419000052, US1424000010, US1424000018, US1431000027, US1239000034, US1550001491, US1338000001, US1550001502, US1550001468, US1611001807, US1611001814, US1611001826, US1611001831, US1611001850, US1248000004, US1248000025, US1248000028, US1248000035, US1517000665, US1517000671, US1517000680, US1443000225, US1724000551, US1724000561, US1729000573, US1729000601, US1729000604, US1311000065
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.