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.
What this means for you
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 and
- Manufacturer
- Invivo Corporation
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
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