GE Healthcare recalls two imaging systems (RIC5-9A-RS and RIC-:5-9-D REALTIME 4D) due to potential transvaginal probe misalignment. Affected units have specific model and serial numbers. Contact GE Healthcare for remedy.
Potential for a transducer mis-alignment in certain transvaginal probes.
GE Healthcare is recalling two imaging systems that may have transvaginal probes that misalign, potentially causing injury during use. This recall affects specific models and serial numbers, and users should contact GE Healthcare for instructions.
The transvaginal probes in certain units may misalign, which could lead to improper imaging or injury during procedures. This misalignment risk is specific to certain models and may not occur in all units.
Healthcare providers using the RIC5-9A-RS System or Refurbish RIC-5-9-D REALTIME 4D models are most at risk. Patients undergoing imaging procedures with these devices could be affected.
Check for model numbers H48701EJ or KTZ157043-R on the device. Serial numbers 205375KR9 or 152323KR2 also identify affected units. The UDI number is available for the first model but not the second.
Identify the model number on the device, which should be H48701EJ or KTZ157043-R.
Reach out to GE Healthcare for specific instructions on how to proceed with the recall.
The transvaginal probes in certain units may misalign, which could lead to improper imaging or injury during procedures.
Check for model numbers H48701EJ or KTZ157043-R and serial numbers 205375KR9 or 152323KR2.
Contact GE Healthcare for specific instructions on how to proceed with the recall.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1965-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1965-2019 from GE Healthcare. 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.
