Class II — Spacelabs Healthcare, Inc.
| Recalling firm | SPACELABS HEALTHCARE, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms. |
| Product | Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2. |
| Quantity | 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, Switzerl… |
| Initiated | 2019-01-28 |
| Classified | 2019-07-22 |
| Terminated | 2022-02-24 |
| Recall number | Z-2035-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Spacelabs Healthcare, Inc. (Z-2035-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83220/
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