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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81047

9 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 14, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Healthcare Diagnostics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

9 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 9

APTIO INPUT/OUTPUT MODULE

Z-0209-2019
Recall number
Z-0209-2019
Initiated
August 14, 2018
Classification
Class II
Status
Terminated
Quantity
441 Aptio Automation Modules

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

Code information

Siemens Material Numbers: 10703031, 10713760, 10713775, 10713772; UDI: 00630414594477

Distribution pattern

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.

device · product 2 of 9

APTIO RACK INPUT MODULE

Z-0210-2019
Recall number
Z-0210-2019
Initiated
August 14, 2018
Classification
Class II
Status
Terminated
Quantity
441 Aptio Automation Modules

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

Code information

Siemens Material Numbers: 10703037, 10711144; UDI: 00630414594477

Distribution pattern

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.

device · product 3 of 9

APTIO CENTRIFUGE MODULE

Z-0211-2019
Recall number
Z-0211-2019
Initiated
August 14, 2018
Classification
Class II
Status
Terminated
Quantity
441 Aptio Automation Modules

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

Code information

Siemens Material Numbers: 10703032, 10713761; UDI: 00630414594477

Distribution pattern

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.

device · product 4 of 9

APTIO 15000 REFRIGERATED STORAGE MODULE

Z-0212-2019
Recall number
Z-0212-2019
Initiated
August 14, 2018
Classification
Class II
Status
Terminated
Quantity
441 Aptio Automation Modules

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

Code information

Siemens Material Numbers: 10703036, 10713762; UDI: 00630414594477

Distribution pattern

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.

device · product 5 of 9

APTIO 9000 REFRIGERATED STORAGE MODULE

Z-0213-2019
Recall number
Z-0213-2019
Initiated
August 14, 2018
Classification
Class II
Status
Terminated
Quantity
441 Aptio Automation Modules

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

Code information

Siemens Material Numbers: 10703049, 10715227; UDI: 00630414594477

Distribution pattern

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.

device · product 6 of 9

APTIO RACK OUTPUT MODULE

Z-0214-2019
Recall number
Z-0214-2019
Initiated
August 14, 2018
Classification
Class II
Status
Terminated
Quantity
441 Aptio Automation Modules

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

Code information

Siemens Material Numbers: 10715432, 10715434; UDI: 00630414594477

Distribution pattern

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.

device · product 7 of 9

STREAMLAB CORE UNIT / LYNX WITH IOM

Z-0215-2019
Recall number
Z-0215-2019
Initiated
August 14, 2018
Classification
Class II
Status
Terminated
Quantity
186 StreamLAB Automation Modules

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

Code information

Siemens Material Numbers: 10444806; UDI: 00630414949765

Distribution pattern

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.

device · product 8 of 9

STREAMLAB - REFRIGERATED STORAGE MODULE 9000

Z-0216-2019
Recall number
Z-0216-2019
Initiated
August 14, 2018
Classification
Class II
Status
Terminated
Quantity
186 StreamLAB Automation Modules

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

Code information

Siemens Material Numbers: 10482426, 10464532, 10635930; UDI: 00630414949765

Distribution pattern

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.

device · product 9 of 9

STREAMLAB - REFRIGERATED STORAGE MODULE 15000

Z-0217-2019
Recall number
Z-0217-2019
Initiated
August 14, 2018
Classification
Class II
Status
Terminated
Quantity
186 StreamLAB Automation Modules

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

Code information

Siemens Material Numbers: 10482428; UDI: 00630414949765

Distribution pattern

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.