CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report

Senographe Pristina recalled by GE Medical Systems, SCS

GE Medical Systems SCS is recalling Senographe Pristina, distributed nationwide in the US. The recall was initiated on 26 Dec 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879

Quantity recalled180 units (60 US; 120 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0862-2024
FDA event ID: 93837
Recalling firm: GE Medical Systems SCS, Buc
Classification: Class II
Status: Ongoing
Recall initiated: 26 Dec 2023
FDA classified: 8 Feb 2024
Reported: 14 Feb 2024
Type: FDA Mandated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

26 Dec 2023	Recall initiated by company
8 Feb 2024	Classified by FDA	+44 days
14 Feb 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.

Product as listed by the FDA

Senographe Pristina

Where it was distributed

Us Nationwide-Worldwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.

Which lots are affected?

GTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879

Where was it sold?

Us Nationwide-Worldwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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