Spacelabs Healthcare recalls Model 92810 Smart Disclosure System software versions 5.00-5.03 that may print patient waveforms from another patient's records.
Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
Spacelabs Healthcare is recalling its Smart Disclosure System Model 92810 software versions 5.00 through 5.03. This could cause patient records to show waveforms from another patient instead of the intended patient, potentially leading to medical errors.
The system may print patient waveforms from another patient's records instead of the intended patient. This could lead to medical errors if healthcare providers use the wrong patient's data for treatment decisions.
Healthcare providers using the Smart Disclosure System Model 92810 with software versions 5.00-5.03 are affected. Patients using this system may be at risk if records are mixed up.
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.
Verify your Smart Disclosure System software version is 5.00, 5.01, 5.02, or 5.03.
The recalled model is Spacelabs Healthcare Smart Disclosure System, Model 92810.
Software versions 5.00, 5.01, 5.02, and 5.03 are affected.
Check for the unique identifier (UDI) 10841522123580 on your system.
We’ve drafted a message you can send Spacel:labs to request your refund or repair — edit it as you like.
Subject: Recall Z-2035-2019 — Spacel:labs Spacel:labs Hello, I own a Spacel:labs that is covered by recall Z-2035-2019 from Spacel:labs. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
