In a telling display of post-spin-off priorities, GE HealthCare issued an urgent “stop use” notice on September 12, 2025, for aging nuclear medicine systems. The directive, reference #40909 and signed by Chief Quality & Regulatory Officer Laila Gurney and Chief Medical Officer Scott Kelley, warns of “life-threatening bodily injury” from potential detector falls. It targets models like the Elscint Cardial, Millennium VG, and Starcam—devices past their “End of Guaranteed Service.”
Yet, the focus lands squarely on the still-prevalent Millennium MG and Myosight systems, unlike the scarcer models listed. Despite no reported incidents, the notice demands immediate shutdown, vague decommissioning aid, and a pitch for “replacement options” via GE reps.
This hands-off approach contrasts sharply with the 2018 response, where GE offered free inspections and repairs for identical risks on the Millennium models. Now, as a standalone public entity fixated on shareholder returns—highlighted by a $1 billion share repurchase program in Q1 2025—GE seems to be slashing legacy support costs to inflate profits, stranding hospitals and endangering patients.
The risk, however, appears exaggerated; the lone documented detector fall involved an Infinia Hawkeye 4 in 2013, suggesting this “urgent” move may prioritize corporate interests over evidence-based safety.
A History of Hazards: From Fixes to Financial Abandonment
GE HealthCare’s nuclear medicine devices have a decade-long track record of detector detachment risks, underscoring persistent design vulnerabilities. In 2013, a 550-pound gamma camera from the Infinia Hawkeye 4 crushed a 66-year-old patient to death at a New York VA hospital, triggering a Class I FDA recall for 1,400 global systems. GE intervened with cost-free inspections and repairs, yet no public settlements materialized, fueling accountability concerns.
By 2018, the Millennium MG, MC, and Myosight—central to the 2025 notice—faced similar scrutiny. On September 14, 2018, GE initiated a Class I recall (reference #40878) after identifying a detector detachment risk due to a motion subsystem error and missing mechanical stopper, posing a “life-threatening bodily harm” threat if a fall occurred during a patient exam. Without any injuries noted or even a reported mechanical incident absent a patient, GE proactively inspected and repaired all affected units worldwide at no cost to customers, completing field actions by November 2018 and terminating the recall in October 2020. This customer-centric approach stands in stark contrast to 2025’s abrupt “stop use” order.
The pattern persisted in 2023 with another Class I recall for the 600/800 Series, where 1,212-pound detectors risked falling due to ball screw failures. GE pledged inspections for supported models, excluding older acquired lines from Elscint and Sopha.
Now, in 2025, GE attributes risks to “transported or relocated without adequate detector support” causing “excessive stress” on mounting mechanisms, declaring it “does not have the ability to correct these devices” and labeling this the “final communication.” A required acknowledgement form builds a liability shield—if incidents occur post-warning, blame shifts to users. The 2023 spin-off of GE HealthCare from GE, designed to “unlock long-term shareholder value” via streamlined operations, appears pivotal. CEO Peter Arduini has touted “strong long-term business prospects” through buybacks and dividends, navigating a $500 million tariff threat with supply chain adjustments—all while trimming service commitments and staff.
Behind the Safety Screen: Profits Over People
While the notice nods to FDA compliance under 21 CFR Part 803, its motives scream self-preservation. The Millennium models, remediated in 2018, are now “no longer serviceable” beyond Guaranteed Service, prompting GE’s exit. Absent post-2018 injuries, the “urgency” likely arises from internal reviews or unreported close calls, forestalling litigation akin to the hushed 2013 aftermath.
The profit angle dominates: Q1 2025 earnings flaunted 3% revenue growth and 10% order increases, triggering the $1 billion buyback to “return capital to shareholders.” Q2 uplifted guidance amid “healthy customer investment,” halving tariff impacts via relocations—at possible supply risks. 2024’s full-year touted 2% organic growth and 98% cash conversion, priming 2025 for “driving long-term value.” The “replacement options” pitch reeks of salesmanship against competitors like Siemens and Philips, converting safety lapses into upgrades while axing support expenses. Observers highlight how such tactics “pivot” clients to premium products, morphing crises into cash flows—all to elevate EPS and repurchases.
Detractors see this as emblematic of medtech flaws: Class I designations flag mortal dangers, but GE’s reactive timeline—bolstered by recent Class II recalls on Varicam and Millennium VG—reveals profit-fueled inertia. Tariffs, eyed at $375 million from China-U.S. ties, are offset by shifts, underscoring margin defense over device durability.
The Human Toll: Hospitals Hamstrung, Patients at Risk
Healthcare providers face disruption: These systems are crucial for cancer, heart, and neuro scans, and sudden halts—especially for prevalent Millennium models—could delay diagnostics in resource-strapped facilities. GE’s “assistance” lacks funding, forcing hospitals to bear decommissioning and upgrade costs amid tight budgets. Yet, amidst fears of losing GE’s service support, relief comes from third-party independent service organizations (ISOs) such as Quality Diagnostic Imaging (NuclearCamera.com), Universal Medical Resources (UniMed.com) and others, which provide readily available parts and service, offering a viable alternative to keep these essential systems running despite GE’s retreat.
Patients bear the brunt: Recurring fall threats conjure horrors of mid-scan crushes. As GE trumpets “high level of safety and quality,” its refusal to extend 2018-style fixes for still-useful devices reeks of abandonment.
Demanding Better: When Will Patients Come First?
GE HealthCare’s 2025 notice averts immediate crises but exposes a profit-over-people ethos. Post-spin-off, shareholder perks like buybacks and dividends thrive while customers scramble. As FDA classifications mount, it’s time for regulators to enforce audits, extended guarantees, and penalties for recidivists. Until then, GE’s “final” edict underscores a harsh truth: In medtech’s boardrooms, shareholders reign supreme, leaving customers—and lives—secondary. For the Millennium MG/Myosight, where no detector fall has ever been recorded, this feels like exploiting an inflated risk to bolster corporate bottom lines.
by: Jeremy Basterash, COO, QDI, LLC, with assistance from Grok, created by xAI