The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU) reagent on-board stability claims, which may cause control failures and/or erroneous patient samples results. The Complaint handling unit has received a total of 2 safety cases (CASE-2023-02027212 and CASE-2023-02045278) and 99 quality cases with the failure mode attributed to Transferrin reagent (OSR6152 / lot 2573) associated with reagent blank shifts for the Reagent 2 (R2), imprecision, calibration failures, erratic Quality Control (QC) recoveries, and/or erroneous high/low (serum, plasma, urine) patient results. The issue was confirmed through internal testing by Beckman Coulter on June 30, 2023. Reagent Blank shifts for R2, imprecision, calibration failures, erratic Quality Control (QC) recoveries, and/or erroneous high/low (serum, plasma, urine) patient results. The issue was confirmed through internal testing by Beckman Coulter on June 30, 2023.
For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.
Compressed helium from the tank can escape and cause the plastic cap to be released into the air unexpectedly, posing an injury hazard due to projectiles striking users and bystanders.
The power bank's internal screws can come loose, causing a short circuit and overheating of the lithium-ion battery, posing a fire hazard. Do not put lithium-ion batteries in the trash or battery recycling boxes found at various retail and home improvement stores. They can cause fires and explosions if they are damaged or crushed and are a hazard when thrown in the trash.
The bottom exterior of the recalled stainless-steel cups contains an accessible solder bead with levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health effects. In addition, the lid can crack and break during use producing sharp edges and small parts, posing choking and laceration hazards to children.
The oven of the gas ranges can emit dangerous levels of carbon monoxide (CO) while in use, posing a serious risk of injury or death from carbon monoxide poisoning.
The bottom exterior of the stainless-steel cups contains an accessible solder bead with levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health effects. In addition, the lid can crack and break during use producing sharp edges and small parts, posing choking and laceration hazards to children.