Integra Camino Advanced Monitor Recalled for Reversed Pressure Display
Integra LifeSciences is recalling 275 Camino Advanced Monitors because a firmware error may display reversed systolic and diastolic intracranial pressure values.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a display error in a medical device used for monitoring intracranial pressure, which poses a risk of harm if clinical decisions are based on incorrect data, but no injuries or illnesses have been reported.
Plain-English summary
Integra LifeSciences Corp. is recalling 275 units of the Integra Camino Advanced Monitor with Waveform Display, Model CAM01. The recall was initiated after a complaint from a single non-US customer reported that when the optional SYS/DIAS mode is used on monitors containing Mod 4 Firmware, the displayed values for systolic and diastolic intracranial pressure (ICP) are reversed.
The affected devices are distributed worldwide, including in the United States and numerous international markets. The source text notes that if the CAM01 is used with an auxiliary bedside monitor, the bedside monitor displays these values correctly. The recall covers specific serial numbers listed in the agency's structured data.
Healthcare facilities and users should check their inventory for the affected serial numbers. The source text does not provide specific consumer instructions beyond the identification of the affected units and the nature of the defect.
The recalled product
- Product
- Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 series of Pressure / Temperature and Pressure Transducer-Tipp
- Manufacturer
- Integra LifeSciences Corp.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Integra LifeSciences Corp.
See all →- HighAURORA Surgiscope System Obturator May Break or Separate
FDA (Devices) · 2025-03-12
- HighMediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect
FDA (Devices) · 2025-02-19
- ModerateIntegra implantable hydrocephalus valve recalled for incorrect product description on labels
FDA (Devices) · 2025-01-29
- ModerateCODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions
FDA (Devices) · 2025-01-29
- ModerateProgrammable Valve Device Recalled Due to Incorrect Product Description Labels
FDA (Devices) · 2025-01-29
Same hazard · display error
See all →- ModerateKico Knee Innovation Recalls ARVIS Surgical Navigation System Due to Sensor Issue
FDA (Devices) · 2026-08-26
- ModerateSpectral Instruments Recalls 35 Ami HTX X-Ray Units
FDA (Devices) · 2026-08-26
- ModerateSpectral Instruments Lago X Medical Device Recalled for Display Glitch
FDA (Devices) · 2026-08-26
- ModerateLinkBio CORE Workstation may display an incorrect planning date
FDA (Devices) · 2026-04-22
- HighHexagon Purus Recalls Tern RC8 Vehicles Due to Brake Display Error
NHTSA · 2026-04-20