An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar confirmed that beginning on January 1, 2020 if a AAA battery is inserted in the recorder and a user attempts to start it, the recorder will display Error: 602 and fail to function for a new patient study. There are no actions that a clinical user can take to clear this error. Even if this error code is displayed, existing ECG recordings stored on the device can still be downloaded via the standard Holter Application Software. Error 602 may be able to be cleared by technical or engineering staff at the customer site.
There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.
There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue.
An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.
Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue.
The product contains sodium hydroxide. The label on the product violates the Federal Hazardous Substance Act (FHSA) by omitting the word "poison" for poisonous chemicals and the mandatory hazard statement on the front on the packaging.
The products contain sodium hydroxide or potassium hydroxide which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of chemical burns and irritation to the skin and eyes. In addition, the label on the product violates the Federal Hazardous Substance Act (FHSA) by omitting the word "poison" for poisonous chemicals and the mandatory hazard statement on the front on the packaging.
The products contain sodium and/or potassium hydroxide which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of chemical burns and irritation to the skin and eyes.
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act (PPPA), posing a risk of poisoning if the contents are swallowed by young children.
The packaging is not child resistant as required by the Poison Prevention Packaging Act. The pain relieving cream contains lidocaine, posing a risk of poisoning to young children if they put it on their skin or ingest it.
The portable generator's inverter assembly can short circuit with the presence of salt water. This causes the unit to smoke or catch fire, posing fire and burn hazards to consumers.
The recalled dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in death or injuries to children.