🏥 Medical Devices • 15,809 recalls
It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective maintenance. Clinical mistreatment may occur if a position error is not detected.
Products without expiration date have the remote potential for minor burn
Smiths Medical ASD
Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette Reservoirs ( Cassette ). Some Cassettes may leak at the sealing area of the pump tube and medication bag. Smiths Medical has received no reports of serious injury or death related to this issue.
The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that connects the occluder blade to the manifold causing an unrecoverable system error, and/or 2) blade may separate from the back plate and cause Slow / No Flow alarm requiring therapy termination.
Puritan Medical Products Co.
Shaft breaks so that adequate patient specimen sample cannot be obtained.
The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder.
Product may have separating or protruding sponges
Products without expiration date have the remote potential for minor burn
Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo Flash, and Head modes. The update improves system start-up behavior and resuming, ECG handling with visual feedback of correct placement of ECG leads and contact quality, and other safety related issues.
Richard-Allan Scientific Company
The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as REF 7501G Cyto-Stain G. The bottle label has the correct lot number of 313833 and EXP date 11/2016. The gallon bottle contains the correct intended contents of 7501R: Cyto-Stain R Stain.
Siemens Healthcare Diagnostics
Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary
Philips Medical Systems
Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float.
Arjo Hospital Equipment AB
The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
Siemens Healthcare Diagnostics
Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary
Siemens Healthcare Diagnostics
Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary
Villa Radiology Systems
The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality
Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.
A device malfunction may cause the biopsy needle to fail to reach the intended target. If location confirming radiographs are not taken and properly evaluated, biopsy site mislocation can result in non-target tissue being sampled rather than target tissue. May result in an incorrect diagnosis.
Philips Medical Systems
In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.
Richard Wolf Medical Instruments
The transformers installed on carts used for Richard Wolf medical video systems may overheat causing smoke and black plastic material to leak from the cart chassis.