RobotRisk › Tecan › 10 Nov 2014

FDA Class III recall: Infinite 200PRO

S2 · 10 Nov 2014 · Tecan

Record

Company	Tecan
Industry	Medical robotics
Type(s)	recall
Date	10 Nov 2014 (day precision)
Time of day	not documented
Location	no physical site (recall / fleet-wide / aggregate record)
Severity	(minor injury or single-unit damage)
Scale	Infinite 200PRO
Confidence	high
Verified flag	Yes - independently re-checked against the cited source

FDA enforcement record (Class III, recall Z-0992-2015): Incorrect lumi firmware version installed (E.027 instead of V2.00)

Publisher: openFDA enforcement · Retrieved: 2026-09-16

Supporting source rows (1)

Date	Supporting source row	Publisher	Link
10 Nov 2014	FDA Class III recall: Infinite 200PRO	openFDA enforcement	openFDA enforcement

Sev	Date	Company	Incident
S3	25 Jul 2016	Tecan	FDA Class II recall: SUNRISE instrument.
S3	29 May 2015	Tecan	FDA Class II recall: Infinite F500, in vitro diagnostic.
S5	11 Mar 2026	Intuitive Surgical	Class I recall of da Vinci SureForm stapler reloads after patient death
S4	25 Mar 2026	Omnicell	FDA Class I recall: Rolls of label stock used with the Omnicell i.v.Station.
S4	~Oct 2017	Monteris Medical	FDA Class I recall: MONTERIS MEDICAL NEUROBLATE SYSTEM, used for
S4	25 Mar 2016	Monteris Medical	FDA Class I recall: NeuroBlate System SideFire Select
S3	21 Jan 2026	Auris Health (J&J MedTech)	FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0
S3	12 Sep 2025	Noah Medical	FDA Class II recall: Brand Name: Galaxy System