RecallRadar

FDA Device recall Z-2335-2015

Biograph mCT Flow Edge-4R, Model Number 10528955

On 2015-08-12 the FDA classified a Class II recall of Biograph mCT Flow Edge-4R, Model Number 10528955 by Siemens Medical Solutions Usa, citing emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2335-2015
ClassificationClass II
Statusterminated
Initiated2015-07-14
Published2015-08-12
Last updated2026-09-13 11:53 UTC
CompanySiemens Medical Solutions Usa
DistributionTX

Product

Biograph mCT Flow Edge-4R, Model Number 10528955

Reason

Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.

Identifiers

code_infoSERIAL NUMBERS: 11002, 11005, 1008

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-2335-2015%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.