RecallRadar

FDA Device recall Z-0265-2016

MODULARIS VARIOSTAR

On 2015-11-18 the FDA classified a Class II recall of MODULARIS VARIOSTAR by Siemens Medical Solutions Usa, citing display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0265-2016
ClassificationClass II
Statusterminated
Initiated2015-09-24
Published2015-11-18
Last updated2026-09-13 11:53 UTC
CompanySiemens Medical Solutions Usa
DistributionGA, KY, LA, MO, MS, NC, PR

Product

MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.

Reason

Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.

Identifiers

code_infomodel# 1157200

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0265-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.