5 product recalls were published during this week. Review the summaries below, then follow the official source before taking action.
Certain patients who have been implanted with S8 (SADP2008-25(B)) or M8 (MADP2008-25(B)) Lead Adaptors received implant cards (patient ID cards) that incorrectly indicate the system is 'MR Conditional', systems with these lead adaptors should be identified as 'MR Unsafe'. The M8 and S8 Lead Adapters of the implanted Senza system are not MR Conditional. The M8 and S8 Lead Adaptors are correctly noted as MR unsafe in the MRI manual.
The size of the product's neck opening is too large and may allow a baby to slip down into the garment, covering the baby's face or posing an entrapment hazard.
The recall is due to the presence of foreign matter (glass) from a packaging fault.
The dummy chain does not comply with the Australian mandatory standard 'Consumer Goods (Babies Dummies and Dummy Chains) Safety Standard 2017'. The chain length may be longer than that specified in the standard.
Due to the circuit board's design, the metal screws that attach the PCIe riser assembly to the frame can cause a short in the printed circuit board and this may overheat and catch fire.