Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Reported: July 31, 2019 Initiated: January 28, 2019 #Z-2035-2019
Product Description
Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Reason for Recall
Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
Details
- Recalling Firm
- Spacelabs Healthcare, Inc.
- Units Affected
- 295 customer sites have the affected software versions
- Distribution
- Distribution was nationwide. There was also government and military distribution. Foreign distribution was made to Argentina, Bahrain, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Costa Rica, Czech Republic, France, Hong Kong, India, Indonesia, Italy, Kuwait, Malaysia, Mexico, Netherlands, Pakistan, Palestine, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, Spain, Switzerland, Taiwan, Trinidad and Tobago, Tunisia, Turkey, UAE, United Kingdom, and Viet Nam.
- Location
- Snoqualmie, WA
Frequently Asked Questions
What product was recalled? ▼
Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.. Recalled by Spacelabs Healthcare, Inc.. Units affected: 295 customer sites have the affected software versions.
Why was this product recalled? ▼
Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 31, 2019. Severity: Moderate. Recall number: Z-2035-2019.
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