November 6, 2019
FDA: Class I recall of Philips Medical System’s Forte Gamma Camera System
Editor's Note
The Food & Drug Administration (FDA) on November 4 identified Philips Medical System’s (Cleveland) recall of its Forte Gamma Camera System as Class I, the most serious.
The recall was initiated because of the potential for the detector, which weighs 660 pounds, to become detached from the device without warning and injure, crush, trap, or cause the death of a patient or a healthcare provider.
The company has received one complaint; no serious injuries or deaths were reported.
Manufacturing and distribution dates were January 1, 1998 to December 31, 2008.
Free Daily News
- FDA: Surgical mesh mini-slings comparable to mid-urethral slings for stress urinary incontinence
- Federal regulations require written consent for pelvic exams at hospitals, medical schools
- Survey: More than half of ED nurses experienced violence in past month
- Heart transplant research proves out 24-hour organ preservation method
- Healthcare safety report: Outcomes improving, but workplace violence persists
- Annual CMS rules support underserved, under-resourced communities, promote value-based care
- Data resource details causes, health implications of sleep deprivation
- Medical error initiative from Joint Commission affiliate NQF targets preventable harm, “never events”
- EPA rule to limit dangerous emissions from medical sterilization plants
- Newly FDA-approved microsurgical system holds promise for training, new treatments
© Access Intelligence, LLC. All rights reserved. | Privacy Policy | Diversity, Equity, Inclusion & Belonging