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

Recall Z-0468-2013 — Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the M

U.S. FDA — Device Enforcement · United States · 2012-10-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0468-2013
Date of alert: 2012-10-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Invivo Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 453564180091

Reported risk: Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression MRI Patient Monitoring System because during transport of the systems cart with a docked Display Controller Unit (DCU), a caster (wheel) may become detached. If this occurs, the cart can become unbalanced and may fall.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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