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Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc. Recalls

All product recalls associated with Siemens Healthcare Diagnostics, Inc..

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Recall Summary

Total Recalls

1000

Past Year

589

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 4921–4940 of 10393 recalls

Dimension Ferritin Flex (Siemens) – negative bias (2019)

Negative Bias with Lot EA9227.

Moderate

FDAJul 15, 2019AK, AZ, AR +32 more• Siemens Healthcare Diagnostics, Inc.

Neomycin Ophthalmic Solution (Pharma Pac) – Quality Control Failure (2019)

CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.

Class IIModerate

FDAJul 12, 2019CA, IN• H J Harkins Company Inc dba Pharma Pac

Merge OrthoPACS (Merge) – image display issue (2019)

Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).

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Moderate

FDAJul 11, 2019Nationwide• Merge Healthcare, Inc.

Merge PACS (Merge) – image display issue (2019)

Moderate

FDAJul 11, 2019Nationwide• Merge Healthcare, Inc.

IMMULITE 2000 Progesterone (Siemens) – result discrepancy (2019)

There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation.

Moderate

FDAJul 10, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

IMMULITE 1000 Progesterone (Siemens) – result discrepancy (2019)

Moderate

FDAJul 10, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Grandio SO Heavy Flow Caps (Voco) – cannula issue (2019)

The metal cannula are potentially too loose and may become loose when applying the filing material.

Low

FDAJul 9, 2019IN, IA, NY• Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany

SPECTRALIS (Heidelberg) – Patient Data Display Error (2019)

Error in the default configuration which could lead to the incorrect display of patient master data.

Low

FDAJul 3, 2019Nationwide• Heidelberg Engineering GmbH Tiergartenstr. 15 Heidelberg Germany

RIC5-9-D Probe (GE Healthcare) – Transducer Misalignment (2019)

Potential for a transducer mis-alignment in certain transvaginal probes.

Low

FDAJul 2, 2019IN, TX• GE Healthcare, LLC

RIC5-9A-RS System (GE Healthcare) – Transducer Misalignment (2019)

Potential for a transducer mis-alignment in certain transvaginal probes.

Low

FDAJul 2, 2019IN, TX• GE Healthcare, LLC

Thor Motor Coach Outlaw (Thor) – Vehicle Control System (2019)

Thor Motor Coach (TMC) is recalling certain 2019-2020 Challenger, Miramar, Magnitude, Outlaw, Omni, and Palazzo motorhomes. The vehicle control system software may cause the slide-out room to move unexpectedly.

High

NHTSAJun 30, 2019Nationwide• THOR MOTOR COACH

Alinity c Lithium Kit (Sentinel) – SmartWash Parameter (2019)

Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results

Low

FDAJun 28, 2019Nationwide• Sentinel CH SpA Via Robert Koch

MAC VU360 (GE Healthcare) – Patient ID Error (2019)

Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report being assigned to the incorrect patient. 2) The MAC VU360 may have the incorrect patient demographics appear on the patient banner. This may result in the ECG report being assigned to the incorrect patient.

High

FDAJun 28, 2019Nationwide• GE Healthcare, LLC