Spacelabs Smart Disclosure System Recalled for Incorrect Waveform Display
Spacelabs Healthcare is recalling the Smart Disclosure System, Model 92810, because it may display or print incorrect patient waveforms for the indicated time.
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 involves a medical device that may provide incorrect clinical data (waveforms), which poses a risk of harm to patients if relied upon for diagnosis or treatment, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Spacelabs Healthcare, LLC is recalling the Spacelabs Smart Disclosure System, Model 92810, which is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The recall is due to a defect where the system may display or print an incorrect waveform for the specific time indicated in the printout or display within the Clinical Access portion of the software.
The affected units are distributed worldwide, including in the United States (specifically Puerto Rico and the states of California, Florida, Iowa, Illinois, Louisiana, Michigan, Minnesota, North Carolina, South Carolina, Texas, and Washington) and in Argentina, Mexico, France, and India. The source text indicates that 27 units are in the US and 17 are international, though it does not specify the total number of affected units or the specific serial numbers, as the product does not have serial numbers.
Healthcare facilities and users should contact Spacelabs Healthcare for instructions on how to address the issue. The product is indicated for use in clinical situations requiring the review of physiological waveform information and alarm events, as well as for retrospective analysis of monitoring patients' ECG waveform data.
The recalled product
- Product
- 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
- Manufacturer
- Spacelabs Healthcare, Llc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- ICS G2 Smart Disclosure Model 92810
- Version 4.03. There are no serial numbers.
Distribution
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