Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
The device does not bear a unique device identifier.
Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 36...
The device does not bear a unique device identifier.
IBA Proton Therapy System - PROTEUS 235
It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used.
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPE...
The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
GEM Premier 5000 PAK; Part No. 00055360010.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Owner's Booklets and Instructions for Use that are used with the following blood...
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
Endo-Model Replacement Plateau; Item Number: 15-8521/11;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE ...
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal.
Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 6...
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.
Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithot...
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box...
Potential for rubber fragment detachment during use.
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Proce...
Behind-the-ear sound processer packaging label is different then included product.
Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Mod...
There is the potential for the length of the trocar shaft to be too long.
CS300 IABP. Software Version CS300 IABP C.01.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
CS100 IABP. Software Version CS100 IABP Q.01.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE...
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
cobas pro integrated solutions with cobas c 503 analytical units: cobas pro s...
Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7...
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/...
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per bo...
Potential for rubber fragment detachment during use.