RecallRadar

FDA Device recall Z-1061-2015

Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body

On 2015-02-25 the FDA classified a Class I recall of Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body by Alltech Medical Systems America, citing the MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1061-2015
ClassificationClass I
Statusterminated
Initiated2015-01-09
Published2015-02-25
Last updated2026-09-13 11:53 UTC
CompanyAlltech Medical Systems America
DistributionMD

Product

Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.

Reason

The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.

Identifiers

code_infoSerial numbers: D-ESP-1001 and D-ESP-1003

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-1061-2015%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.