
Boston Scientific · Model Vercise Gevia
DBS System Next generation rechargeable DBS system compatible with the Vercise Cartesia™ Directional Lead to provide the first and only rechargeable with MICC Directional System2 for DBS with Full-Body MRI access.
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
Symptoms: Low signal-to-noise, shading, or a dead region in images; coil not detected or fails the coil check.
Root cause: Damaged RF coil element, a coil-cable / connector fault, or a preamp fault.
Symptoms: Geometric distortion, gradient-amplifier faults, acoustic change, over-temperature trips.
Root cause: Gradient-amplifier fault, gradient-coil cooling problem, or a gradient-coil fault.
Symptoms: Rising helium boil-off, cold-head noise or stall, He level dropping, compressor alarms.
Root cause: Cold-head at end of life, a helium-compressor fault, or a chilled-water problem.
Symptoms: System-cooling alarms, gradient or RF over-temperature, scans aborting.
Root cause: Facility chilled-water supply, the heat exchanger, or internal pumps.
Symptoms: Table will not dock, drive or index; landmarking errors.
Root cause: Table drive, docking sensor, or encoder fault.
Symptoms: Recon errors, host hangs, images will not reach PACS.
Root cause: Recon or host computer fault, or the network / storage.
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
Planned replacement; He boil-off rises as it wears.
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| RF receive coil (exchange) | Major service part | $$$$ | Moderate |
| Cold head Planned replacement; He boil-off rises as it wears. | Periodic replacement | $$$$ | Difficult |
| Helium compressor / adsorber | Major service part | $$$$ | Difficult |
| Gradient amplifier module | Major service part | $$$$ | Expert-level |
| Chilled-water pump / heat exchanger | Major service part | $$$ | Difficult |
| Patient table drive / encoder | Major service part | $$$ | Difficult |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
Synced live from the FDA openFDA API.
Flash may be protruding from the lumen of the catheter shaft. If this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device during the procedure.
Missing holes: Catheters are missing the catheter's side holes.
Excess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an embolization resulting from the excess resin detaching from the device during the procedure.
Boston Scientific is voluntarily recalling one lot/batch of Katzen Infusion Wires because they have identified that the label on the carton may indicate a different length device than what is actually in the carton. The affected batch was manufactured using the Katzen Core Assembly of 146 cm, instead of a 177cm assembly.
One lot of product, Stainless Steel Greenfield Vena Cava Filter, may have the incorrect expiration date of 2008-07 and the correct date is 2008-06.
The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip.
Lack of assurance of sterility (pre-sterilization bioburden limits exceeded)
Boston Scientific discovered through an internal inspection process that the PTFE (polytetrafluoroethylene) coating is not consistently adhering to the transition area of the distal end of the guide wires which may cause PTFE to flake off.
Gaps were identified between polymer segments on the 7F Wiseguide Guide Catheter in which the PTFE was not properly laminated to the braid of the catheter. This delamination of the PTFE from the braid could compromise the device delivery.
There have been reports of detachment at the bond between the carrier capsule and the outer sheath of the Greenfield Vena Cava Filters with 12 Fr Femoral introducer Systems manufactured before Marcyh 10, 2004. If the capsule should detach during an implantation procedure, there is a risk of cardiac and pulmonary embolization.
The device has the potential for overheating its transformer and has the potential for fire hazard.
The device has the potential for overheating its transformer and has the potential for fire hazard.
Describe a symptom or error code. Bio answers from this device's own documented error codes, failure modes, parts, and guides.
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