RecallRadar

FDA Device recall Z-2337-2015

Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302

On 2015-08-12 the FDA classified a Class II recall of Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302 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-2337-2015
ClassificationClass II
Statusterminated
Initiated2015-07-14
Published2015-08-12
Last updated2026-09-13 11:53 UTC
CompanySiemens Medical Solutions Usa
DistributionTX

Product

Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302

Reason

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

Identifiers

code_infoSERIAL NUMBERS: 1041, 1042

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-2337-2015%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.