CLASS II Device recall · Reported 3 Oct 2018 · FDA Enforcement Report

Dx-d 600 Product Usage: The Dx-d 600 system is a ceiling mounted recalled

Agfa N.V is recalling Dx-d 600 Product Usage: The Dx-d 600 system is a ceiling mounted, distributed nationwide in the US. The recall was initiated on 15 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Nos: A5430000015 A5430000020 A5430000030 A5430000042 A5430000045 A5430000052 A5430000053 A5430000054 A5430000057 A5430000058 A5430000060 A5430000061 A5430000063 A5430000066 A5430000067 A5430000068 A5430000074 A5430000079 A5430000081 A5430000085 A5430000089 A5430000095 A5430000096 A5430000100 A5430000105 A5430000106 A5430000107 A5430000108 A5430000119 A5430000121 A5430000124 A5430000125 A5430000130 A5430000131 A5430000132 A5430000133 A5430000137 A5430000143 A5430000144 A5430000149 A5430000156 A5430000162 A5430000165 A5430000166 A5430000172 A5430000176 A5430000177 A5430000183 A5430000184 A5430000199 A5430000206 A5430000207 A5430000215 A5430000218 A5430000222 A5430000224 A5430000225 A5430000226 A5430000228 A5430000229 A5430000234 A5430000237 A5430000238 A5430000242 A5430000246 A5430000247 A5430000248 A5430000249 A5430000263 A5430000264 A5430000272 A5430000275 A5430000276 A5430000279 A5430000281 A5430000285 A5430000293 A5430000295 A5430000296 A5430000297 A5430000298 A5430000299 A5430000300 A5430000303 A5430000304 A5430000305 A5430000306 A5430000311 A5430000312 A5430000313 A5430000320 A5430000321 A5430000322 A5430000323 A5430000324 A5430000331 A5430000332 A5430000338 A5430000350 A5430000351 A5430000354 A5430000357 A5430000358 A5430000359 A5430000360 A5430000368 A5430000369 A5430000374

Quantity recalled108

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3245-2018
FDA event ID: 81046
Recalling firm: Agfa N.V, Mortsel
Classification: Class II
Status: Terminated
Recall initiated: 15 Aug 2018
FDA classified: 25 Sep 2018
Reported: 3 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

15 Aug 2018	Recall initiated by company
25 Sep 2018	Classified by FDA	+41 days
3 Oct 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear. If the two cables that support the equipment to its roof anchor break, the equipment might fall and cause harm to the patient, or others.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.

Where it was distributed

Worldwide Distribution - US Nationwide in the states of CA, DC, FL, IL, IN, KS, LA, MA, MN, MO, NV, NY, OH, OR, SC and TN. Foreign distribution to Canada.

Nationwide California District of Columbia Florida Illinois Indiana Kansas Louisiana Massachusetts Minnesota Missouri Nevada New York Ohio Oregon South Carolina Tennessee

Questions about this recall

Is Dx-d 600 Product Usage: The Dx-d 600 system is a ceiling mounted recalled?

Yes. Agfa N.V recalled Dx-d 600 Product Usage: The Dx-d 600 system is a ceiling mounted on 15 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-3245-2018.

Why was it recalled?

Which lots are affected?

Serial Nos: A5430000015 A5430000020 A5430000030 A5430000042 A5430000045 A5430000052 A5430000053 A5430000054 A5430000057 A5430000058 A5430000060 A5430000061 A5430000063 A5430000066 A5430000067 A5430000068 A5430000074 A5430000079 A5430000081 A5430000085 A5430000089 A5430000095 A5430000096 A5430000100 A5430000105 A5430000106 A5430000107 A5430000108 A5430000119 A5430000121 A5430000124 A5430000125 A5430000130 A5430000131 A5430000132 A5430000133 A5430000137 A5430000143 A5430000144 A5430000149 A5430000156 A5430000162 A5430000165 A5430000166 A5430000172 A5430000176 A5430000177 A5430000183 A5430000184 A5430000199 A5430000206 A5430000207 A5430000215 A5430000218 A5430000222 A5430000224 A5430000225 A5430000226 A5430000228 A5430000229 A5430000234 A5430000237 A5430000238 A5430000242 A5430000246 A5430000247 A5430000248 A5430000249 A5430000263 A5430000264 A5430000272 A5430000275 A5430000276 A5430000279 A5430000281 A5430000285 A5430000293 A5430000295 A5430000296 A5430000297 A5430000298 A5430000299 A5430000300 A5430000303 A5430000304 A5430000305 A5430000306 A5430000311 A5430000312 A5430000313 A5430000320 A5430000321 A5430000322 A5430000323 A5430000324 A5430000331 A5430000332 A5430000338 A5430000350 A5430000351 A5430000354 A5430000357 A5430000358 A5430000359 A5430000360 A5430000368 A5430000369 A5430000374

Where was it sold?

Worldwide Distribution - US Nationwide in the states of CA, DC, FL, IL, IN, KS, LA, MA, MN, MO, NV, NY, OH, OR, SC and TN. Foreign distribution to Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Agfa N.V

All 7

Reported	Class	Recall	Company	Reason	Where
4 Sep 2024Device	CLASS II	DR 800. Digital Radiography X-ray System recalled by Agfa N.V	Agfa N.V	Other	Nationwide
10 Apr 2024Device	CLASS II	Agfa DX-D 100 system-Digital Radiography mobile X-ray System recalled	Agfa N.V	Device Malfunction	Nationwide
10 Jun 2020Device	CLASS II	Agfa Digital Radiography X- Ray system DR recalled by Agfa N.V	Agfa N.V	Other	Nationwide
25 Mar 2020Device	CLASS II	AGFA Digital Radiography X- Ray system DR recalled by Agfa N.V	Agfa N.V	Other	Nationwide
7 Aug 2019Device	CLASS II	Agfa Digital Radiography X- Ray system DR 800 with Musica Dynamic recalled	Agfa N.V	Device Malfunction	Nationwide

Other Spinal Implants recalls

All 1,157

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2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide