Medical Devices Recalls

Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.

There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved for calibration, after a calibration test has been placed and completed, the same rack may be used to place both a patient order and a calibration order. When a patient sample and a non-barcoded calibrator tube is processed on the rack, the calibration result will be reported as a patient result. Issue 2: calibration with expired calibrator. They both may cause erroneous patient results, but the probability of serious adverse health consequences or death is unlikely.

Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)

A broken fuse inside the laser that was caused by a short circuit at PIN 4 of the DOOR CTRL. This short circuit was caused by a badly positioned cable that made contact with the housing/frame and caused a short circuit and destroyed the fuse in the laser. This caused the shutter to remain in its most recent state; either in an open or closed position. Once the fuse was destroyed the shutter could not be operated.

If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software update will be released to correct issue.

If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.

Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.

Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.

Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.

Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)

Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.

Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.

The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser marking process.

Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are not compatible with the indicated pumps.