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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80057

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 20, 2017
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Invivo Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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 (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves.

Z-2115-2018
Recall number
Z-2115-2018
Initiated
November 20, 2017
Classification
Class II
Status
Ongoing
Recalling firm
Invivo Corporation
Quantity
1,040 units (USA) and 7 units (Foreign)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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, 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Distribution pattern

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.