RobotRisk / Tecan / 2016-07-25

medical robotics · recall

FDA Class II recall: SUNRISE instrument.

S3 · 07/25
2016 · Tecan

Record

Company	Tecan
Category	medical robotics
Type	recall
Date	07/25 2016
Time of day	not documented
Location	no physical site (recall / fleet-wide / aggregate record)
Severity	S3 (recall, enforcement, or fleet-wide fault)
Scale	SUNRISE instrument.
Confidence	high
Verification	Yes - adversarially checked against the cited source
Source	openFDA enforcement

What happened

FDA enforcement record (Class II, recall Z-2661-2016): The batteries have the potential to overheating, melt or char.

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S5	2026-03-11	Intuitive Surgical	Class I recall of da Vinci SureForm stapler reloads after patient death
S3	2026-01-21	Auris Health (J&J MedTech)	FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0
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S3	2025-04-23	Virtual Incision	FDA Class II recall: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical sur
S3	2025-02-26	Intuitive Surgical	Class II recall of da Vinci 5 foot pedal over spring failure

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