Spacelabs Smart Disclosure System Recalled for Patient Data Mismatch
Spacelabs Healthcare is recalling the Smart Disclosure System because patient records were printed with waveforms from other patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 where incorrect patient data (waveforms) was printed, creating a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Spacelabs Healthcare, Inc. is recalling the Smart Disclosure System, Model 92810, which is a component of the Intesys Clinical Suite (ICS) G2. The recall affects installations with software versions 5.00, 5.01, 5.02, or 5.03.
The recall was initiated after reports indicated that patient records were printed with the correct patient demographics but contained waveforms belonging to a different patient. This discrepancy poses a risk to patient safety by potentially providing incorrect clinical data to healthcare providers.
The affected software was distributed nationwide, including to government and military facilities, as well as to numerous foreign countries. A total of 295 customer sites have the affected software versions. Healthcare facilities should contact Spacelabs Healthcare for instructions on how to address the issue.
The recalled product
- Product
- Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
- Manufacturer
- Spacelabs Healthcare, Inc.
- Affected units
- 295
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 (5)
- All affected Smart Disclosure installations with software versions 5.00
- 5.01
- 5.02
- or 5.03
- UDI 10841522123580.
Distribution
Distributed nationwide across the United States.
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