Recall Z-1615-2015— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2015-04-02, terminated 2016-08-17. It names 3 FDA 510(k) clearances: K130276, K112999, K073604. Product: Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM. The Dimension EXL clinical chemistry system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use.. Reason: Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been installed with a non-standard instrument power plug.The use of a non-standard plug configuration as described may lead to a potential electrical hazard. The likelihood of potential clinical impact or injury due to this issue is extremely low..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-02
- Terminated
- 2016-08-17
- Firm location
- Newark, DE, United States
510(k) clearances named in this recall
3 on FDA's record- K130276 — DIMENSION EXL WITH LM SYSTEM
- K112999 — DIMENSION CLINICAL CHEMISTRY SYSTEM
- K073604 — DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM. The Dimension EXL clinical chemistry system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use.
Reason for recall
Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been installed with a non-standard instrument power plug.The use of a non-standard plug configuration as described may lead to a potential electrical hazard. The likelihood of potential clinical impact or injury due to this issue is extremely low.
Data sourced from openFDA. This site is unofficial and independent of the FDA.