CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system
Medical device recall Z-1355-2023. Published in FDA’s Enforcement Report on Apr 19, 2023.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 19, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 512 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
512 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN: (01)00884838076747 (Model 709030), (01)00884838101456 (Model 709031; Serial Numbers: 10000000 10000001 10000002 10000003 10000004 10000006 10000007 10000010 10000011 10000012 10000013 10000014 10000015 10000016 10000019 10000020…
Every code shown here, 2,000 characters
GTIN: (01)00884838076747 (Model 709030), (01)00884838101456 (Model 709031; Serial Numbers: 10000000 10000001 10000002 10000003 10000004 10000006 10000007 10000010 10000011 10000012 10000013 10000014 10000015 10000016 10000019 10000020 10000021 10000022 10000023 10000024 10000025 10000026 10000027 10000029 10000030 10000031 10000032 10000034 10000035 10000036 10000037 10000038 10000040 10000041 10000042 10000043 10000044 10000045 10000046 10000047 10000048 10000049 10000050 10000051 10000052 10000053 10000054 10000055 10000056 10000057 10000058 10000060 10000061 10000063 10000064 10000065 10000066 10000067 10000068 10000069 10000070 10000071 10000072 10000073 10000075 10000076 10000078 10000079 10000080 10000081 10000082 10000083 10000087 10000089 10000090 10000092 10000093 10000094 10000095 10000096 10000097 10000099 10000100 10000102 10000103 10000104 10000107 10000108 10000109 10000111 10000112 10000114 10000115 10000116 10000117 10000118 10000119 10000121 10000122 10000124 10000125 10000126 10000127 10000130 10000131 10000133 10000134 10000135 10000136 10000137 10000138 10000139 10000140 10000144 10000145 10000149 10000151 10000152 10000156 10000165 10000166 10000168 10000169 10000170 10000171 10000174 10000176 10000178 10000179 10000180 10000184 10000185 10000186 10000187 10000188 10000189 10000190 10000191 10000194 10000198 10000199 10000202 10001000 10001001 10001010 10001070 10001071 10001072 10001073 10001074 10001075 10001076 10001078 10001079 10001080 10001081 10001082 10001083 10001084 10001085 10001086 10001087 10001088 10001089 10001090 10001091 10001092 10001093 10001094 10001095 10001096 10001097 10001098 10001099 10001100 10001216 10001218 17000018 17000164 18000069 11201-10 24233-03 24592-122 28 7175_04 7896_04 SN16000001 SN16000002 SN16000003 SN16000004 SN16000006 SN16000007 SN16000008 SN16000009 SN17000001 SN17000002 SN17000003 SN17000004 SN17000006 SN17000007 SN17000008 SN17000009 SN17000010 SN17000011 SN17000012 SN17000013 SN17000014 SN17000015…
FDA’s list runs to 5,111 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide. Global Distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 21, 2021.
- FDA classified it on Apr 10, 2023.
- FDA’s Enforcement Report published it on Apr 19, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America Llc, of Cambridge, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,111 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.