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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83271

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 02, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE Healthcare, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D

Z-1964-2019
Recall number
Z-1964-2019
Initiated
July 02, 2019
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
3 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for a transducer mis-alignment in certain transvaginal probes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model KTZ303987-R - Serial Number (UDI Number): 226914KR0 (01008406821084301118032721226914KR0), 198026KR7 (Not Available), 220616KR7 (01008406821084301117091521220616KR7), 205375KR9 (01008406821085531116071121205375KR9)

Distribution pattern

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

device · product 2 of 2

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

Z-1965-2019
Recall number
Z-1965-2019
Initiated
July 02, 2019
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
2 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for a transducer mis-alignment in certain transvaginal probes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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