FDA Device recall Z-2442-2015
Guardian Real-Time Monitor, Model No. CSS7100
- FDA Device
- Class II
- terminated
- Published 2015-09-02
On 2015-09-02 the FDA classified a Class II recall of Guardian Real-Time Monitor, Model No. CSS7100 by Medtronic Minimed, citing medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System because it has a language translation error that impacts the Finnish language. Specifica….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2442-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-22 |
| Published | 2015-09-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Minimed |
| Distribution | n/a |
Product
Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management.
Reason
Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System because it has a language translation error that impacts the Finnish language. Specifically, the Monitor has a Finnish translation error in Predictive Alerts setting: the on-screen Finnish translation for LOW/HIGH is reversed as HIGH/LOW.
Identifiers
| code_info | GLU100968U GLU102603U GLU102604U GLU102606U GLU102611U GLU102633U GLU105144U GLU104941U GLU105216U GLU113873U…GLU100968U GLU102603U GLU102604U GLU102606U GLU102611U GLU102633U GLU105144U GLU104941U GLU105216U GLU113873U KIT207482U KIT207495U KIT209292U KIT209308U KIT209282U KIT209297U KIT207481U KIT207491U KIT207494U KIT209284U KIT227732U KIT227735U KIT227740U KIT227746U KIT229227U KIT229224U KIT237462U KIT207486U KIT241304U KIT241308U KIT241292U KIT242887U KIT210467U KIT210465U KIT242885U KIT242888U KIT242890U KIT242893U KIT210485U KIT254775U KIT254779U KIT247924U KIT258441U KIT249491U KIT263472U KIT226461U KIT258451U KIT249497U KIT249498U KIT259531U KIT265811U KIT258445U KIT267592U KIT267602U KIT255788U KIT267584U KIT267573U KIT267597U KIT267576U KIT267599U KIT265806U KIT259534U KIT265804U KIT270748U KIT270754U KIT270759U KIT269538U KIT269540U KIT269535U KIT270765U KIT270767U KIT270769U KIT270773U KIT273802U KIT280803U KIT280805U KIT280806U KIT280807U KIT280808U KIT280816U KIT286957U KIT280818U KIT280819U KIT2 |
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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-2442-2015%22
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