CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Check against the official notice below — it lists the full affected range.
Integra LifeSciences Corp. is recalling 1,210 CereLink ICP Monitor units (Catalog No. 826820 and 826820P) distributed worldwide. The intracranial pressure monitors can display inaccurate readings that drift to -50 mmHg, which is outside the normal range, and may show an error message stating "sensor or extension cable failure!" The company determined the problem is caused by electrical interference from a component on the monitor's circuit board and from the surrounding environment.
The affected monitors were distributed across numerous countries including the United States, Canada, Australia, New Zealand, and throughout Europe, the Middle East, and other regions. The recall covers all serial numbers of these units. The source document does not specify what remedy an affected consumer should pursue.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide Distribution: US nationwide, Australia, New Zealand, Canada, Hong Kong, Pakistan, Georgia, Saudi Arabia, Israel, South Africa, United Arab Emirates, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Portugal, Switzerland, Spain, Sweden, Slovakia, and United Kingdom. Quantity: 1,210 units Lot/code info: UDI-DI- 10381780533778; All serial numbers.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.