Integra recalls CereLink ICP monitors with catalog numbers 826820 and 826820P due to potential ICP readings drifting to -50 mmHg, which could trigger error messages.
Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by electrical interference from a component of the monitor's circuit board and from the environment.
Integra is recalling CereLink ICP monitors that may show incorrect intracranial pressure readings as low as -50 mmHg. This could cause the device to display an error message about sensor failure, potentially leading to inaccurate health monitoring.
The monitor's circuit board can experience electrical interference from environmental factors or internal components, causing ICP readings to drift to -50 mmHg. This may trigger an error message indicating sensor or extension cable failure, but does not cause immediate harm.
Patients using the CereLink ICP monitor for intracranial pressure monitoring are affected. Those with medical devices that require precise pressure readings are at higher risk.
Check for catalog numbers 826820 or 826820P on the monitor. The device is sold as an intracranial pressure monitor with a unique serial number.
Look for error messages like "sensor or extension cable failure!" or unusually low ICP readings.
Integra has received complaints that ICP readings may drift to -50 mmHg due to electrical interference in the circuit board.
The recall record does not specify a remedy, so no action is required beyond checking for error messages.
The recall record states that the hazard may cause incorrect readings but does not mention serious injury risks.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1395-2022 — Integra Integra Hello, I own a Integra that is covered by recall Z-1395-2022 from Integra. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
