Food, drugs, devices › Siemens Healthcare Diagnostics, Inc.
Device recall: APTIO INPUT/OUTPUT MODULE
FDA enforcement event 81047 is a device recall by Siemens Healthcare Diagnostics, Inc. of Tarrytown, NY, initiated 14 Aug 2018 and classified Class II, with 9 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 4 Sep 2020. Initiation: voluntary: firm initiated. Siemens Healthcare Diagnostics, Inc. has 333 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Siemens Healthcare Diagnostics, Inc., Tarrytown, NY.
Reason for recall
"The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0209-2019 | APTIO INPUT/OUTPUT MODULE | 441 Aptio Automation Modules | Class II | Terminated | 31 Oct 2018 |
| Z-0210-2019 | APTIO RACK INPUT MODULE | 441 Aptio Automation Modules | Class II | Terminated | 31 Oct 2018 |
| Z-0211-2019 | APTIO CENTRIFUGE MODULE | 441 Aptio Automation Modules | Class II | Terminated | 31 Oct 2018 |
| Z-0212-2019 | APTIO 15000 REFRIGERATED STORAGE MODULE | 441 Aptio Automation Modules | Class II | Terminated | 31 Oct 2018 |
| Z-0213-2019 | APTIO 9000 REFRIGERATED STORAGE MODULE | 441 Aptio Automation Modules | Class II | Terminated | 31 Oct 2018 |
| Z-0214-2019 | APTIO RACK OUTPUT MODULE | 441 Aptio Automation Modules | Class II | Terminated | 31 Oct 2018 |
| Z-0215-2019 | STREAMLAB CORE UNIT / LYNX WITH IOM | 186 StreamLAB Automation Modules | Class II | Terminated | 31 Oct 2018 |
| Z-0216-2019 | STREAMLAB - REFRIGERATED STORAGE MODULE 9000 | 186 StreamLAB Automation Modules | Class II | Terminated | 31 Oct 2018 |
| Z-0217-2019 | STREAMLAB - REFRIGERATED STORAGE MODULE 15000 | 186 StreamLAB Automation Modules | Class II | Terminated | 31 Oct 2018 |
Context
Other enforcement events for Siemens Healthcare Diagnostics, Inc.
All 333 events for Siemens Healthcare Diagnostics, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Sep 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.