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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 3801–3820 of 10393 recalls

ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162... (Siemens Healthcare Diagnostics, Inc.) – potential sample identification (sid)... (2021)

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

Moderate

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, ... (Siemens Healthcare Diagnostics, Inc.) – potential sample identification (sid)... (2021)

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

Moderate

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail... (Arjohuntleigh Magog, Inc.) – the spreader bar can disconnect from ... (2021)

The spreader bar can disconnect from the scale bottom attachment.

Moderate

1...189 190191192 193...520

Page 191 of 520Next

FDA

Mar 4, 2021

AZ, CA, CO +9 more

• Arjohuntleigh Magog, Inc.

RayCare 3B (3.1.0.60341) - Product Usage: Intended Use On... (RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden) – patient related messages created in r... (2021)

Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later

Low

FDAMar 3, 2021Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

BCS XP System: Multipurpose system for in vitro coagulati... (Siemens Healthcare Diagnostics, Inc.) – siemens healthcare diagnostics produc... (2021)

Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.

Moderate

FDAMar 2, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Ultrasonic pulsed doppler imaging system - Product Usage:... (Hitachi Medical Systems America Inc) – arietta 850 software version 4 (2021)

Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transducer aperture settings in the SWE function. When the affected software with SWE function is used in conjunction with the C252 probe, this error can result in out of specification MI/TI acoustic output. The MI/TI acoustic output is higher than regulatory limits.

High

FDAMar 1, 2021Nationwide• Hitachi Medical Systems America Inc

Oshkosh S-Series (Oshkosh) – Axle Shaft Defect (2021)

Oshkosh Corporation (Oshkosh) is recalling certain 2020-2021 S-Series vehicles. The rear axle output shaft may not have been heat-treated properly, which could cause the shaft to fracture.

High

NHTSAFeb 26, 2021Nationwide• OSHKOSH

Femoral Angiography Drape (Cardinal Health) – Manufacturing Variance (2021)

Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.

Low

FDAFeb 25, 2021Nationwide• Cardinal Health 200, LLC

Femoral Angiography Drape (Cardinal Health) – Manufacturing Variance (2021)

Low

FDAFeb 25, 2021Nationwide• Cardinal Health 200, LLC

In-View Clear Leggings (Cardinal Health) – Manufacturing Variance (2021)

Low

FDAFeb 25, 2021Nationwide• Cardinal Health 200, LLC

Backflush Brush Needles (Dutch Ophthalmic) – Mislabeled Size (2021)

Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 mm) instead of the correct size of 23 gauge/0.6 mm and the correct product code 1281.B1D06

Low

FDAFeb 25, 2021IL, IN, MO +1 more• Dutch Ophthalmic USA, Inc.

In-View Clear Leggings (Cardinal Health) – Manufacturing Variance (2021)

Low

FDAFeb 25, 2021Nationwide• Cardinal Health 200, LLC

CT Systems (Philips) – CT Couch Actuator Failure (2021)

Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position.

High

FDAFeb 24, 2021Nationwide• Philips Healthcare (Suzhou) Co., Ltd. Suzhou Industrial Park No.

Bee Free Children's Helmets (Shenzhen Haochen) – Head Injury Risk (2021)

This recall involves Bee Free-branded children's multi-purpose helmets which can be used for multiple sports. The helmets were sold in size small, fitting head circumference from 48 cm to 53 cm (18.9 to 21.2 inches). The helmets were sold in yellow with black straps and black clip. Bee Free is printed on the back of the helmets. Model RPBFHYS is printed on a label on the inside of the helmet. S for small is printed on another label also on the inside of the helmet. Only the small-sized helmets are included in this recall.

High

CPSCFeb 24, 2021Nationwide• Shenzhen Haochen Industrial Co. Ltd., of China

Incisive CT X-Ray System (Philips) – Gantry Actuator Failure (2021)

Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may tilt forward slowly, in a worst case, reaching to the tilt limit angle +31degrees

High

FDAFeb 22, 2021Nationwide• Philips North America Llc

RayStation Software (RaySearch) – Dose Labeling Error (2021)

For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams can be used manually, in scripting, or as part of the Automated breast planning feature. In some cases, when merging two beams where the first beam has clinical dose and the second beam has approximate dose, the dose of the resulting beam will be labeled as Clinical, although dose for some of the beam segments is still calculated with the SVD dose engine and it should be labeled Approximate: Mixed dose. The difference between approximate and final Clinical dose is in most cases small, but there can be body sites such as lung where the difference can be significant.

Low

FDAFeb 22, 2021Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

Yum Crumbs (Sapphire Exchange) – Undeclared Red #40 (2021)

Undeclared Allergen

Undeclared Red #40

Class IIILow

FDAFeb 19, 2021Nationwide• THE SAPPHIRE EXCHANGE

Fludeoxyglucose F 18 (General Hospital) – Sterility Concern (2021)

Lack of Assurance of Sterility

Class IIModerate

FDAFeb 17, 2021Nationwide• The General Hospital Corporation

Judkins Pack (Cardinal Health) – Component Mixing Issue (2021)

Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect medication label sheet throughout the specific Presource kit SANHDJTVCF Judkins Pack lot # 525067.

Low

FDAFeb 11, 2021VA• Cardinal Health 200, LLC

HeartStart HS1 OnSite Defibrillator (Philips) – Recall Notification Failure (2021)

Customers were not notified of previous recalls associated with various defibrillator models.

Low

FDAFeb 9, 2021CA, CT, FL +9 more• Philips North America LLC