Medical Devices Recalls

GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

A potential issue with the seal integrity of header bag packaging.

GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.

Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record

A potential issue with the seal integrity of header bag packaging.

A potential issue with the seal integrity of header bag packaging.

GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound

Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.

Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped", which could result in hyperglycemia.

An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.

Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter.

It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy.

Potential for a weak seal in some units resulting in compromise in sterility.

Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.

There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Product lacks 510(k) clearance.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Product lacks 510(k) clearance.