Agfa HealthCare Issues Nationwide Communication of DX-D 100 Mobile X-ray and Other Medical Device Products Damaged by Hurricane Sandy in 2012

Press release
Greenville, SC
August 16, 2016 4:00 PM CET

Agfa HealthCare Corporation (Agfa), Greenville, South Carolina, is initiating this nationwide communication regarding certain medical devices that were damaged by Hurricane Sandy in 2012. The medical devices in question had been stored in Agfa's Carlstadt, New Jersey warehouse in October 2012. The warehouse flooded during Hurricane Sandy, and the building and some of the inventory stored in the building experienced major water and mold damage.

Agfa made arrangements with a third party contractor to have the medical devices in question be destroyed or recycled. However, some of the products from this inventory recently have been discovered by Agfa to be in the U.S. market and were apparently not destroyed, as Agfa had instructed. Agfa hereby advises healthcare consumers and buyers that due to contamination and water damage, these devices are not suitable for use in any facility environment for testing, patient care or diagnostic purposes and may pose a risk to patients and users.

Additionally, the DX-D 100 Mobile X-ray products from this inventory (identified by serial number in the list below), do not have the mandatory service corrections and labeling that Agfa had issued after October 2012, which are required by the U.S. Food & Drug Administration (“U.S. FDA”) and other regulatory authorities for these devices. This inventory should have been destroyed and should not be present in the market, and Agfa will not be responsible for requests for service or quality issues that may occur with these specific DX-D 100 Mobile X-ray units or any of the other medical devices from this damaged inventory (listed below with serial numbers).

The U.S. FDA has been apprised of this action. No injuries have been reported to date arising from use of any of the products in this Hurricane Sandy-damaged stock.

Consumers or buyers who have any of the products listed in this communication should stop using the products immediately and should not sell the product to anyone.
Consumers or buyers with questions may contact Agfa HealthCare anytime, 24/7 at

Dial: 1-877-777-2432
Press: 1 for Support Tickets; then 4 for Imaging Call Center

Any adverse reactions experienced with the use of any of these medical device products, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Line Items	Medical Devices	Serial Number	QTY
1	DX-D 100	A5411000087	1
2	DX-D 100	A5411000077	1
3	DX-D 100	A5410000040	1
4	DX-D 100	A5410000045	1
5	DX-D 100	A5411000061	1
6	DX-D 100	A5411000045	1
7	DX-D 100	A5411000067	1
8	DX-D 100	A5411000059	1
9	DX-D 100	A5411000075	1
10	DX-D 100	A5411000058	1
11	DX-D 100	A5411000035	1
12	DX-D 100	A5411000066	1
13	DX-D 100	A5411000051	1
14	DX-D 100	A5411000113	1
15	DX-D 100	A5411000111	1
16	DX-D 100	A5411000107	1
17	DX-D 100	A5411000106	1
18	DX-D 100	A5411000105	1
19	DX-D 100	A5411000102	1
20	DX-D 100	A5411000101	1
21	DX-D 100	A5411000099	1
22	DX-D 100	A5411000095	1
23	DX-D 100	A5411000094	1
24	DX-D 100	A5411000086	1
25	DX-D 100	A5411000031	1
		TOTAL DX-D 100	25
26	CR 85-X DIGITIZER	23102	1
27	CR 85-X DIGITIZER	6005	1
28	CR 85-X DIGITIZER	6004	1
29	CR 85-X DIGITIZER	5975	1
30	CR 85-X DIGITIZER	5974	1
		TOTAL CR 85-X DIGITIZER	5
31	CR 35-X DIGITIZER	8496	1
32	CR 35-X DIGITIZER	8502	1
33	CR 35-X DIGITIZER	8540	1
34	CR 35-X DIGITIZER	8550	1
35	CR 35-X DIGITIZER	8553	1
		TOTAL CR 35-X DIGITIZER	5
36	CR 30-X DIGITIZER	50840	1
37	CR 30-X DIGITIZER	50867	1
38	CR 30-X DIGITIZER	50800	1
		TOTAL CR 30-X DIGITIZER	3
39	CR10-X 5151/100	1207	1
40	CR10-X 5151/100	1208	1
41	CR10-X 5151/100	1210	1
42	CR10-X 5151/100	1214	1
43	CR10-X 5151/100	1246	1
44	CR10-X 5151/100	1247	1
45	CR10-X 5151/100	1251	1
46	CR10-X 5151/100	1265	1
47	CR10-X 5151/100	1266	1
48	CR10-X 5151/100	1321	1
49	CR10-X 5151/100	1338	1
50	CR10-X 5151/100	1367	1
51	CR10-X 5151/100	1183	1
52	CR10-X 5151/100	1199	1
53	CR10-X 5151/100	1200	1
		TOTAL CR10-X	15
54	DRYSTAR 5302 5366/100	20192	1
55	DRYSTAR 5302 5366/100	20231	1
56	DRYSTAR 5302 5366/100	20232	1
		TOTAL DRYSTAR 5302	3
57	DRYSTAR 5503	19680	1
58	DRYSTAR 5503	19679	1
59	DRYSTAR 5503	19682	1
60	DRYSTAR 5503	19588	1
61	DRYSTAR 5503	19678	1
		TOTAL DRYSTAR 5503	5
62	DRYSTAR AXYS 5367/100	4678	1
63	DRYSTAR AXYS 5367/100	5657	1
64	DRYSTAR AXYS 5367/100	5723	1
65	DRYSTAR AXYS 5367/100	5724	1
66	DRYSTAR AXYS 5367/100	5773	1
67	DRYSTAR AXYS 5367/100	5775	1
68	DRYSTAR AXYS 5367/100	5777	1
69	DRYSTAR AXYS 5367/100	5778	1
70	DRYSTAR AXYS 5367/100	5780	1
71	DRYSTAR AXYS 5367/100	5784	1
72	DRYSTAR AXYS 5367/100	5786	1
		TOTAL DRYSTAR AXYS	11
73	DX-D 30C	200001	1
74	DX-D 30C	200003	1
75	DX-D 30C	200010	1
76	DX-D 30C	200011	1
77	DX-D 30C	200021	1
78	DX-D 30C	200056	1
79	DX-D 30C	100074	1
80	DX-D 30C	100072	1
81	DX-D 30C	100076	1
82	DX-D 30C	100078	1
83	DX-D 30C	100082	1
84	DX-D 30C	100084	1
85	DX-D 30C	200027	1
86	DX-D 30C	200028	1
87	DX-D 30C	200029	1
88	DX-D 30C	200046	1
89	DX-D 30C	A8207001090	1
90	DX-D 30C	200168	1
91	DX-D 30C	200074	1
92	DX-D 30C	200167	1
93	DX-D 30C	200075	1
94	DX-D 30C	200166	1
95	DX-D 30C	200076	1
96	DX-D 30C	200150	1
97	DX-D 30C	200079	1
98	DX-D 30C	200122	1
99	DX-D 30C	200081	1
100	DX-D 30C	200082	1
101	DX-D 30C	200066	1
		TOTAL DX-D 30C	29
102	DX-M DIGITIZER	1976	1
103	DX-M DIGITIZER	1977	1
104	DX-M DIGITIZER	1975	1
105	DX-M DIGITIZER	1978	1
106	DX-M DIGITIZER	1971	1
107	DX-M DIGITIZER	1982	1
108	DX-M DIGITIZER	1970	1
109	DX-M DIGITIZER	1985	1
110	DX-M DIGITIZER	1967	1
111	DX-M DIGITIZER	1990	1
112	DX-M DIGITIZER	1965	1
113	DX-M DIGITIZER	1992	1
114	DX-M DIGITIZER	1964	1
115	DX-M DIGITIZER	2036	1
116	DX-M DIGITIZER	1963	1
117	DX-M DIGITIZER	2037	1
118	DX-M DIGITIZER	1962	1
119	DX-M DIGITIZER	2038	1
120	DX-M DIGITIZER	1927	1
121	DX-M DIGITIZER	2039	1
122	DX-M DIGITIZER	2040	1
123	DX-M DIGITIZER	2042	1
124	DX-M DIGITIZER	2047	1
125	DX-M DIGITIZER	2048	1
126	DX-M DIGITIZER	2051	1
127	DX-M DIGITIZER	2052	1
128	DX-M DIGITIZER	2056	1
129	DX-M DIGITIZER	10428	1
130	DX-M DIGITIZER	CARL10818	1
131	DX-M DIGITIZER	10431	1
132	DX-M DIGITIZER	10820	1
133	DX-M DIGITIZER	10435	1
134	DX-M DIGITIZER	10819	1
		TOTAL DX-M DIGITIZER	33
135	DX-G	1564	1
		TOTAL DX-G	1
136	DRYSTAR 5300 5365/100	8399	1
		TOTAL DRYSTAR 5300 5365/100	1
137	Varian Detector CSI	2124172NQ02	1
		TOTAL Varian Detector CSI	1

Miriam Ladin
Marketing Communications Director - North America
One Crosswind Road
RI 02891 Westerly, Rhode Island (USA)
tel:+1 (0)401 604 22 03
fax:+1 (0)401 596 85 62
miriam.ladin@agfa.com

Agfa HealthCare Issues Nationwide Communication of DX-D 100 Mobile X-ray and Other Medical Device Products Damaged by Hurricane Sandy in 2012

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