Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2264-2023 — Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0372

U.S. FDA — Device Enforcement · United States · 2023-05-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2264-2023
Date of alert: 2023-05-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Olympus Corporation of the Americas
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00815686020576

Reported risk: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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