CLASS II Device recall · Reported 24 Jul 2019 · FDA Enforcement Report

Repair RIC5-9A-RS System, imaging, pulsed doppler recalled

GE Healthcare is recalling Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D, distributed in Texas. The recall was initiated on 2 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel H48701EJ; Serial Number 205375KR9; (UDI Number) 01008406821085531116071121205375KR9. Model KTZ157043-R Serial Number 152323KR2 (UDI Number Not Available)

Quantity recalled2 devices

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-1965-2019
FDA event ID: 83271
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 2 Jul 2019
FDA classified: 12 Jul 2019
Reported: 24 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

2 Jul 2019	Recall initiated by company
12 Jul 2019	Classified by FDA	+10 days
24 Jul 2019	Published in enforcement report	+12 days

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

Reason for recall

Potential for a transducer mis-alignment in certain transvaginal probes.

Product as listed by the FDA

Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D

Where it was distributed

Distribution in the US to Texas. International distribution to France, Greece and Switzerland.

Texas

Questions about this recall

Why was it recalled?

Potential for a transducer mis-alignment in certain transvaginal probes.

Which lots are affected?

Model H48701EJ; Serial Number 205375KR9; (UDI Number) 01008406821085531116071121205375KR9. Model KTZ157043-R Serial Number 152323KR2 (UDI Number Not Available)

Where was it sold?

Distribution in the US to Texas. International distribution to France, Greece and Switzerland.

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.

Other products in this recall event

1 other product · FDA event 83271

This product is part of a recall event; the main page for the event is Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D recalled.

Reported	Class	Recall	Company	Reason	Where
24 Jul 2019	CLASS II	Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D recalled	GE Healthcare	Other	TX

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