Lower riskMedical device recall · FDA · Published January 28, 2019
Spacelabs Healthcare Smart Disclosure System Model 92810: Patient Record Mix-Up Risk
Spacelabs Healthcare recalls Model 92810 Smart Disclosure System software versions 5.00-5.03 that may print patient waveforms from another patient's records.
“Spacelabs Healthcare Smart Disclosure System Model 92810: Patient Record Mix-Up Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69075-spacelabs-healthcare-smart-disclosure-system-model-92810-patient-record-mix. Based on FDA recall #Z-2035-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2035-2019%22&limit=1).
The FDA announced on Jan. 28, 2019, that Spacelabs Healthcare recalled its Smart Disclosure System Model 92810 because patient records were printed with another patient's waveforms. The agency classified the recall as Class II.
How to tell if you have it
Brand: Spacelabs
Product: Spacelabs Healthcare Smart Disclosure System, Model 92810
Software versions: 5.00, 5.01, 5.02, or 5.03
UDI: 10841522123580
The hazard
According to the FDA, several reports indicated that patient records were printed with correct demographics but contained another patient's waveforms.
Context
GovInfoNow's records show Spacelabs Healthcare has had 10 other recalls since Jan. 17, 2018. Other recent recalls of similar products include Nova Biomedical StatStrip Glucose Meter System Recall (July 29, 2026), GE Healthcare Centricity Enterprise Archive V2/V3/V4 Software Recall (July 31, 2026), and GE Healthcare Workflow Core Services V8 Recall (July 31, 2026).
How to tell if you have this one
Check if your Smart Disclosure System has software versions 5.00, 5.01, 5.02, or 5.03. The product includes a unique identifier (UDI) 10841522123580.
Brand
Spacel:labs
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your Smart Disclosure System software version is 5.00, 5.01, 5.02, or 5.03.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2035-2019 (January 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2035-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.