Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dime
FDA device recall Z-1615-2015 · posted 2015-05-14 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Action taken
- Siemens sent an Urgent Field Safety Notice, dated April 2015, was issued for distribution to affected customers in Japan to notify them of the issue. A Siemens Service Representative will visit customer sites to inspect the Dimension instrument power plug and wall outlet configuration. If the instrument is configured with a non-standard 15 Amp plug/outlet or a 20 Amp twist lock plug, Siemens will correct the issue identified, ensuring that the system is installed according to the instrument requirements.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 17801
- Distribution
- Distributed in the country of Japan.
- Date initiated
- 2015-04-02
- Date posted
- 2015-05-14
- Date terminated
- 2016-08-17
- Location
- Newark, DE
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION EXL WITH LM SYSTEM (K130276) | Siemens Healthcare Diagnostics, Inc. | 2013-03-22 |
| DIMENSION CLINICAL CHEMISTRY SYSTEM (K112999) | Siemens Healthcare Diagnostics | 2011-11-22 |
| DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD (K073604) | Dade Behring, Inc. | 2008-03-13 |