Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Check against the official notice below — it lists the full affected range.
Spacelabs Healthcare, Inc. is recalling the Smart Disclosure System, Model 92810, which is part of the Intesys Clinical Suite (ICS) G2. The recall was initiated because patient records were being printed with one patient's correct demographic information but another patient's waveforms, creating a mismatch between patient identity and medical data in printed documents.
The affected product includes all Smart Disclosure installations running software versions 5.00, 5.01, 5.02, or 5.03 (UDI 10841522123580). The system was distributed nationwide and internationally to 295 customer sites, including government and military facilities, with distribution extending to countries including Canada, Mexico, Brazil, China, India, and numerous others. The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
Reason for recall: Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms. 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, Quantity: 295 customer sites have the affected software versions Lot/code info: All affected Smart Disclosure installations with software versions 5.00, 5.01, 5.02, or 5.03, UDI 10841522123580.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.