RecallRadar

FDA Device recall Z-0118-2016

CIOS ALPHA

On 2015-11-04 the FDA classified a Class II recall of CIOS ALPHA by Siemens Medical Solutions Usa, citing patient procedure interruption due to a potential system failure.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0118-2016
ClassificationClass II
Statusterminated
Initiated2015-08-17
Published2015-11-04
Last updated2026-09-13 11:53 UTC
CompanySiemens Medical Solutions Usa
DistributionUS

Product

CIOS ALPHA; image intensified fluoroscopic x-ray system

Reason

patient procedure interruption due to a potential system failure

Identifiers

code_info
model #10308191 with serial numbers: Serial 11032 10073 11132 11044 11005 10115 11056 10057 10076 10019 1003…model #10308191 with serial numbers: Serial 11032 10073 11132 11044 11005 10115 11056 10057 10076 10019 10035 11074 11075 11077 11083 11124 10078 11119 11103 11105 11013 10021 10037 10063 11106 10082 11098 11094 10089 11080 11009 11018 11082 10058 10098 11120 11134 11015 11016 11038 10116 11035 11107 11064

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-0118-2016%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.