GE Medical Systems recalls Senographe Pristina X-ray machines with Efficiency Suite 2 due to intermittent failure of the X-ray exposure termination audible signal, which may lead to incomplete imaging. Affected units have specific GTINs listed in the recall notice.
X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
GE Medical Systems is recalling Senographe Pristina X-ray machines with Efficiency Suite 2 because the audible signal that stops X-ray exposure may not work properly. This could cause incomplete imaging during procedures, but it does not pose a risk of injury to patients or staff.
The X-ray exposure termination audible signal may not be emitted as required by regulations. This means the machine might not properly stop X-ray exposure after a scan, potentially leading to incomplete imaging results.
Healthcare facilities using Senographe Pristina X-ray machines with Efficiency Suite 2 are likely affected. Medical staff and patients using these machines may be at risk of incomplete imaging during procedures.
Check for the Senographe Pristina model with Efficiency Suite 2. Affected units have specific GTINs listed in the recall notice: 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879.
Verify if your Senographe Pristina X-ray machine has one of the listed GTINs: 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879.
The recall addresses a potential issue with X-ray exposure termination signals, which could lead to incomplete imaging. However, it does not pose a risk of injury to patients or staff.
Check the GTINs listed in the recall notice: 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879.
The recall does not specify a remedy, so affected facilities should contact GE Medical Systems for further instructions.
We’ve drafted a message you can send GE Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0862-2024 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-0862-2024 from GE Medical Systems. 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.
