Medical equipment, implants, and diagnostic devices
Philips Medical Systems (Cleveland)
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather than a 10 second ramp up period. The pump may have migrated out of position and possibly caused injury. The positioning and suction alarms were also disabled.
Argon Medical Devices
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
BD has decided to initiate a voluntary recall due to a confirmed complaint trend for droplets of fluid separating from the sealed surface of the MaxZero connector, following disconnection.
Hitachi Medical Systems America
There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Philips Medical Systems (Cleveland)
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.
Ethicon Endo-Surgery
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Medical Components, Inc
When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves do not appear on the screen, in surface or internal mode. If the C3 application is not operating properly, the PICC procedure must be completed without using alternate methods to confirm PICC tip placement.
Complaints were received on the product, such as the re-breather bag would not fill/inflate or the oxygen line pops off after the oxygen is turned on due to a clogged port.
Ethicon Endo-Surgery
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Valeritas, Incorporated
There is a potential for "No Needle Demo Units" to contain a needle.
Baxter Healthcare
TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of 25 amps for 10 seconds.
Implant Direct Sybron Manufacturing
The action is being initiated due to incorrect assembly of the scan adapter . The result of the incorrect assembly could cause the clinician not to be able to capture the position and orientation of a dental implant(s) or lab analog during the digital scanning process which could result in a delay for the patient.
Alto Development
Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.