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Results of post market surveillance revealed that under certain circumstances the room configuration parameters of the system are set to default values. If these values are larger than the actual room dimensions, a collision with the ceiling or wall…

Siemens Healthcare is informing customers with a preventive measure to exclude any potential risk of patient injury caused the footrest detaching from the patient table during an examination. Recall start date: December 15, 2022

Siemens Healthcare Diagnostics Inc. has confirmed an issue through complaint investigation. The issue has the potential to affect the recovery of po2 in quality control (qc) at elevation with barometric pressures <730 mmhg on epoc sensor configuration…

Emergent received 3 complaints from customers between 18 Oct 2022 - 15 Nov 2022 related to leaking packets. Product in leaking packets may not perform as effectively as intended.  Recall start date: November 24, 2022

Some electrode pads used with the hs1/onsite/home AED have been observed to experience gel separation from the foam/tin backing when peeled from the yellow plastic liner. The gel may fold onto itself, resulting in reduced surface area of gel on the pad.…

The software may not be able to identify that the orders are for the same patient and may not perform the discrepant result checks. Recall start date: November 18, 2022

There is a potential for false positive results for flu B and RSV while using the list numbers and lot numbers referenced above associated with the manufacture of these lots. There is also a potential for delayed results when using these lots as reactive…

This recall addresses a product concern regarding the drapes in the kit. The supplier (3M) decided to recall the drapes in the kit because it was confirmed that the liner on the adhesive component of the affected drapes is difficult to remove without…

Issue 1: "password store corrupted" error message during system bootup in rare cases (e.g., if an unplanned and unguided shutdown is triggered via the power button) it is possible that during a later syngo start-up an error message occurs instead of the…

Ortho received 166 world-wide complaints for Vitros iPTH reagent pack related to observations of lower-than-expected iPTH patient and quality control (QC) results with the affected lots listed above. Customers reported the negatively biased iPTH results…

Baxter Corporation is communicating two separate, but associated, issues related to Revaclear dialyzers. The first issue is linked to reports of internal blood leaks being caused by a twisted gasket in the dialyzer, prompting Baxter to recall the…

During a recent investigation, 3m confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Although the acceptance criteria for the device was met upon…

Manufacturer initiated recall notifying users of lot-specific open vial stability claim reduction = IFU correction to affected lots. Open vial stability for troponin I present in OCRD-UL, OCRD-I and OCRD-SP does not meet the 15 day claim in IFU. Analysis…

Cardinal Health is issuing this correction to make you aware of a labeling update on its reusable hot and cold gel pack products. Specifically, a caution statement is being added to ensure the products are not used on infants or neonates. Recall start…

Bolt shearing at the head or on the threaded portion which may cause strut dissociation from the frame. No patient injury, delay in surgery or other adverse event resulted. Recall start date: September 16, 2022