Villa Sistemi Medicali Recalls Apollo DRF X-ray Tables Due to Chain Failure
Villa Sistemi Medicali is recalling seven Apollo DRF X-ray tables because the angulation chain may fail early due to metal fatigue.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where a mechanical failure is identified, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for unreported harm.
Plain-English summary
Villa Sistemi Medicali S.P.A. is recalling seven units of the Apollo DRF X-ray table, Model Number 9784220831. The recall is being issued to update the Instructions for Use and Service Manual to require the replacement of the angulation chain after eight years of service.
Testing revealed that the angulation chain might fail before its expected lifetime of ten years due to metal fatigue under severe workload conditions. The affected units were distributed in the United States, including the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, and Puerto Rico.
The specific serial numbers for the affected units are 08090531, 09090591, 10040680, 15051450, 11020798, 17011602, and 17041639. Users should check their equipment serial numbers and follow the updated service instructions to replace the angulation chain.
The recalled product
- Product
- Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that allows to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are…
- Manufacturer
- Villa Sistemi Medicali S.P.A.
- Category
- Medical Device — X-ray Equipment
- Hazard
- Affected units
- 7
Distribution
Part of a larger recall action
This product is one of 4 recalled by Villa Sistemi Medicali S.P.A. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Villa Sistemi Medicali S.P.A.
See all →- HighVilla Sistemi Medicali Recalls Apollo EZ X-Ray Table Due to Chain Failure
FDA (Devices) · 2020-01-08
- HighVilla Sistemi Medicali Recalls Apollo X-ray Tables Due to Chain Failure Risk
FDA (Devices) · 2020-01-08
- HighVilla Sistemi Medicali Recalls Juno DRF X-Ray Systems Due to Chain Failure
FDA (Devices) · 2020-01-08
- SevereVilla Sistemi Medicali Recalls Apollo X-Ray Systems Due to Footrest Detachment
FDA (Devices) · 2017-03-15
- SevereVilla Sistemi Medicali Recalls Apollo EZ X-Ray Systems Due to Footrest Detachment
FDA (Devices) · 2017-03-15
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- SevereApollo DRF X-ray Systems Recalled Due to Footrest Detachment Hazard
FDA (Devices) · 2017-03-15
- SevereVilla Radiology Systems Recalls Apollo DRF X-Ray Systems Due to Injury Risk
FDA (Devices) · 2017-02-01
- SevereVilla Sistemi Medicali Recalls Apollo X-Ray Systems Due to Footrest Detachment
FDA (Devices) · 2017-03-15
- SevereVilla Sistemi Medicali Recalls Apollo EZ X-Ray Systems Due to Footrest Detachment
FDA (Devices) · 2017-03-15
- HighVilla Sistemi Medicali Recalls Juno DRF X-Ray Systems Due to Footrest Detachment
FDA (Devices) · 2017-03-15
- SevereVilla Radiology Systems Recalls Apollo X-Ray Systems Due to Injury Risk
FDA (Devices) · 2017-02-01