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

Recall Z-0694-2013 — Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to

U.S. FDA — Device Enforcement · United States · 2012-12-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0694-2013
Date of alert: 2012-12-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Spacelabs Healthcare, Llc
Product category: device
Product type: Devices

Reported risk: Displaying or printing of an incorrect waveform for the time indicated in the printout or display in the Spacelabs Healthcare Intesys Clinical Suite (ICS) G2, Version 4.03, Clinical Access portion of Smart Disclosure, Model 92810.

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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