00840682143271 · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

Initiated	Recall #	Class	Status	Reason	Quantity	Link basis
2019-07-02	Z-1964-2019	Class II	Terminated	Potential for a transducer mis-alignment in certain transvaginal probes.Distribution: Distribution in the US to Texas. International distribution to France, Greece and Switzerland.	3 devices	clearance family

Regulatory clearances

510(k)K181985Substantially equivalent (SESE) · 2018-11-15clearance family

Predicate lineage

K181985
- K172342
- K173555
  - K163077
    - K152309
  - K170445

Cited as predicate by: K192152, K192159, K192505, K210699, K240115, K240684

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2013-11-20	NAI	No action indicated	GE HEALTHCARE AUSTRIA GMBH & CO OG	0

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