Z-0217-2019Class II

Streamlab - Refrigerated Storage Module 15000

Name: Z-0217-2019 Streamlab - Refrigerated Storage Module 15000
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2018-08-14
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-08-14 / Terminated / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of STREAMLAB - REFRIGERATED STORAGE MODULE 15000 on 2018-08-14. FDA classified it as Class II and gives the reason as "The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0217-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-14
Posted: 2018-10-23
Terminated: 2020-09-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Streamlab - Refrigerated Storage Module 15000
Product code: LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Reason for recall: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Correction notification letters dated 8/14/18 were distributed to customers.
Quantity in commerce: 186 StreamLAB Automation Modules
Distribution: The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV. The products were distributed to the following foreign countries: Australia, Austria, Bangladesh, Belgium, Canada, Croatia, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Libya, Netherlands, Philippines, Portugal, Saudi Arabia, Slovakia, Slovenia, Spain, Taiwan, Thaliand, UAE, UK.
Product codes and lots: Siemens Material Numbers: 10482428; UDI: 00630414949765

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0217-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0209-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0210-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0211-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0212-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0213-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0214-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0215-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0216-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0217-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23

Product code LXG

K082638Class IIAdvia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. / cleared 2009-02-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)