95,025 total recalls in our database
There are potential issues related to the operational state of the scanner, specifically for transport and inadvertent system shutdowns. There could be a possibility of potential delay in patient treatment if proper use instructions are not followed.
Shanghai United Imaging Healthcare Co.
1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions.
The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the prescribed ventilation not being delivered to the patient. These cracks could possibly leak if they reach a significant size and pose a serious heath risk to patient.
Arrow International
The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.
The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may not change to the energy setting selected, or the device may deliver a shock with an energy level different from the setting selected by the user. These device behaviors could result in a delay in therapy or a failure to deliver the intended therapy.
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
A missing component (hand suction pump) in the emergency medical kits.
The UDI on the device label indicates incorrect manufacturer.
Ortho Clinical Diagnostics
The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.
Arrow International
The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.
Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
Arrow International
The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. The Holder may not always snap and securely hold the oxygenator as intended.
Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits.
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
Ortho Clinical Diagnostics
The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.
Arrow International
The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.
Shanghai United Imaging Healthcare Co.
1) Service function problem may cause false marking of a bad channel resulting in ring artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions (N/A for Serial No. 200036)
Smith & Nephew
Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.