Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2115-2018·Announced 2018-06-13

Invivo Xper Flex Cardio Physiomonitoring System Recalled for Software Defect

Invivo Corporation is recalling Xper Flex Cardio Physiomonitoring Systems because users may inadvertently close the Full Disclosure Control Window using the ESC key.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a user interface error that could interrupt monitoring, but no injuries, illnesses, or deaths are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Invivo Corporation is recalling the Xper Flex Cardio Physiomonitoring System. The system is used to facilitate invasive investigation of heart and vascular disease and to display and analyze various physiological waveforms, including surface ECG, respiration, invasive pressure, SpO2, End Tidal CO2, and non-invasive pressure.

The recall is due to a software issue where, while in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window by pressing the ESC key instead of the X icon in the upper right corner of the window.

Approximately 1,040 units in the USA and 7 units in foreign countries are affected. The devices were distributed nationwide in the US and in Canada, China, Great Britain, and Korea. Invivo Corporation is the recalling firm.

The recalled product

Product: 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…
Manufacturer: Invivo Corporation
Category: Medical Device — Cardiovascular Monitoring
Hazard: software-defect
user-interface-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Same manufacturer · Invivo Corporation

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Invivo Xper Flex Cardio Physiomonitoring System Software Recall
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Same hazard · software defect